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Psoriatic arthritis and psoriasis have high economic burdens and the total annual costs were similar between the 2 diseases, but the combination of both yielded the highest costs, according to an abstract published at the European League Against Rheumatism annual meeting.

The researchers analyzed 318 patients with psoriasis (n = 196), PsA (n = 43), or both (n = 79) in the COEPSO (Evaluation of Costs in patients with Psoriatic Disease) trial, an observational, retrospective, cross-sectional study in 22 Spanish centers from February 2017 to February 2018.

The authors obtained information from the year prior to the study on direct nonhealth care services (including social services, home care, and private health and nonhealth professionals), as well as indirect and total costs (direct nonhealth care and indirect costs) related to the disease. They calculated out-of-pocket costs, which were specified directly by the patients, and loss of productivity costs, which were gauged by the average salaries for the occupation specific by the patients.

Patients with both psoriasis and PsA had higher annual total costs than patients who only had 1 disease (75.5% higher than patients with psoriasis and 60.9% higher than patients with PsA). However, the total costs for patients with psoriasis and PsA were similar.

The average annual total cost per patient was 1042.71 ($1186.64) for psoriasis, 1137.84 ($1294.90) for PsA, and 1830.26 ($2082.89) for both. The breakdown of direct nonhealth care costs vs indirect costs were:

PsA and [psoriasis] have proved to be diseases with a high economic burden, and the total costs were mainly driven by direct non-healthcare costs, the authors concluded.

Reference

Vincente E, Castaeda S, Llamas Velasco M, et al. Cost of illness in patients with psoriasis and psoriatic arthritis. COEPSO Study. Presented at: EULAR 2020; June 3-6, 2020; Abstract OP0262-HPR. https://ard.bmj.com/content/79/Suppl_1/164.2

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Indirect Nonhealth Care Costs Drive Total Costs in Psoriatic Arthritis and Psoriasis - AJMC.com Managed Markets Network

The global Psoriasis market focuses on encompassing major statistical evidence for the Psoriasis industry as it offers our readers a value addition on guiding them in encountering the obstacles surrounding the market. A comprehensive addition of several factors such as global distribution, manufacturers, market size, and market factors that affect the global contributions are reported in the study. In addition the Psoriasis study also shifts its attention with an in-depth competitive landscape, defined growth opportunities, market share coupled with product type and applications, key companies responsible for the production, and utilized strategies are also marked.

This intelligence and 2026 forecasts Psoriasis industry report further exhibits a pattern of analyzing previous data sources gathered from reliable sources and sets a precedented growth trajectory for the Psoriasis market. The report also focuses on a comprehensive market revenue streams along with growth patterns, analytics focused on market trends, and the overall volume of the market.

Moreover, the Psoriasis report describes the market division based on various parameters and attributes that are based on geographical distribution, product types, applications, etc. The market segmentation clarifies further regional distribution for the Psoriasis market, business trends, potential revenue sources, and upcoming market opportunities.

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Key players in the global Psoriasis market covered in Chapter 4:, Celgene Corporation, Takeda Pharmaceutical Company Limited, Pfizer Inc., Stiefel Laboratories Inc., Amgen Inc., Biogen Idec, Novartis AG, Eli Lilly and Company, Johnson and Johnson (Janssen Biotech Inc.), AbbVie Inc.

In Chapter 11 and 13.3, on the basis of types, the Psoriasis market from 2015 to 2026 is primarily split into:, Systemic, Phototherapy, Topical Treatment, Others

In Chapter 12 and 13.4, on the basis of applications, the Psoriasis market from 2015 to 2026 covers:, Injectable, Tropical, Oral

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:, North America (Covered in Chapter 6 and 13), United States, Canada, Mexico, Europe (Covered in Chapter 7 and 13), Germany, UK, France, Italy, Spain, Russia, Others, Asia-Pacific (Covered in Chapter 8 and 13), China, Japan, South Korea, Australia, India, Southeast Asia, Others, Middle East and Africa (Covered in Chapter 9 and 13), Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Others, South America (Covered in Chapter 10 and 13), Brazil, Argentina, Columbia, Chile, Others

The Psoriasis market study further highlights the segmentation of the Psoriasis industry on a global distribution. The report focuses on regions of North America, Europe, Asia, and the Rest of the World in terms of developing business trends, preferred market channels, investment feasibility, long term investments, and environmental analysis. The Psoriasis report also calls attention to investigate product capacity, product price, profit streams, supply to demand ratio, production and market growth rate, and a projected growth forecast.

In addition, the Psoriasis market study also covers several factors such as market status, key market trends, growth forecast, and growth opportunities. Furthermore, we analyze the challenges faced by the Psoriasis market in terms of global and regional basis. The study also encompasses a number of opportunities and emerging trends which are considered by considering their impact on the global scale in acquiring a majority of the market share.

The study encompasses a variety of analytical resources such as SWOT analysis and Porters Five Forces analysis coupled with primary and secondary research methodologies. It covers all the bases surrounding the Psoriasis industry as it explores the competitive nature of the market complete with a regional analysis.

Brief about Psoriasis Market Report with [emailprotected] https://hongchunresearch.com/report/psoriasis-market-40648

Some Point of Table of Content:

Chapter One: Report Overview

Chapter Two: Global Market Growth Trends

Chapter Three: Value Chain of Psoriasis Market

Chapter Four: Players Profiles

Chapter Five: Global Psoriasis Market Analysis by Regions

Chapter Six: North America Psoriasis Market Analysis by Countries

Chapter Seven: Europe Psoriasis Market Analysis by Countries

Chapter Eight: Asia-Pacific Psoriasis Market Analysis by Countries

Chapter Nine: Middle East and Africa Psoriasis Market Analysis by Countries

Chapter Ten: South America Psoriasis Market Analysis by Countries

Chapter Eleven: Global Psoriasis Market Segment by Types

Chapter Twelve: Global Psoriasis Market Segment by Applications12.1 Global Psoriasis Sales, Revenue and Market Share by Applications (2015-2020)12.1.1 Global Psoriasis Sales and Market Share by Applications (2015-2020)12.1.2 Global Psoriasis Revenue and Market Share by Applications (2015-2020)12.2 Injectable Sales, Revenue and Growth Rate (2015-2020)12.3 Tropical Sales, Revenue and Growth Rate (2015-2020)12.4 Oral Sales, Revenue and Growth Rate (2015-2020)

Chapter Thirteen: Psoriasis Market Forecast by Regions (2020-2026) continued

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List of tablesList of Tables and FiguresTable Global Psoriasis Market Size Growth Rate by Type (2020-2026)Figure Global Psoriasis Market Share by Type in 2019 & 2026Figure Systemic FeaturesFigure Phototherapy FeaturesFigure Topical Treatment FeaturesFigure Others FeaturesTable Global Psoriasis Market Size Growth by Application (2020-2026)Figure Global Psoriasis Market Share by Application in 2019 & 2026Figure Injectable DescriptionFigure Tropical DescriptionFigure Oral DescriptionFigure Global COVID-19 Status OverviewTable Influence of COVID-19 Outbreak on Psoriasis Industry DevelopmentTable SWOT AnalysisFigure Porters Five Forces AnalysisFigure Global Psoriasis Market Size and Growth Rate 2015-2026Table Industry NewsTable Industry PoliciesFigure Value Chain Status of PsoriasisFigure Production Process of PsoriasisFigure Manufacturing Cost Structure of PsoriasisFigure Major Company Analysis (by Business Distribution Base, by Product Type)Table Downstream Major Customer Analysis (by Region)Table Celgene Corporation ProfileTable Celgene Corporation Production, Value, Price, Gross Margin 2015-2020Table Takeda Pharmaceutical Company Limited ProfileTable Takeda Pharmaceutical Company Limited Production, Value, Price, Gross Margin 2015-2020Table Pfizer Inc. ProfileTable Pfizer Inc. Production, Value, Price, Gross Margin 2015-2020Table Stiefel Laboratories Inc. ProfileTable Stiefel Laboratories Inc. Production, Value, Price, Gross Margin 2015-2020Table Amgen Inc. ProfileTable Amgen Inc. Production, Value, Price, Gross Margin 2015-2020Table Biogen Idec ProfileTable Biogen Idec Production, Value, Price, Gross Margin 2015-2020Table Novartis AG ProfileTable Novartis AG Production, Value, Price, Gross Margin 2015-2020Table Eli Lilly and Company ProfileTable Eli Lilly and Company Production, Value, Price, Gross Margin 2015-2020Table Johnson and Johnson (Janssen Biotech Inc.) ProfileTable Johnson and Johnson (Janssen Biotech Inc.) Production, Value, Price, Gross Margin 2015-2020Table AbbVie Inc. ProfileTable AbbVie Inc. Production, Value, Price, Gross Margin 2015-2020Figure Global Psoriasis Sales and Growth Rate (2015-2020)Figure Global Psoriasis Revenue ($) and Growth (2015-2020)Table Global Psoriasis Sales by Regions (2015-2020)Table Global Psoriasis Sales Market Share by Regions (2015-2020)Table Global Psoriasis Revenue ($) by Regions (2015-2020)Table Global Psoriasis Revenue Market Share by Regions (2015-2020)Table Global Psoriasis Revenue Market Share by Regions in 2015Table Global Psoriasis Revenue Market Share by Regions in 2019Figure North America Psoriasis Sales and Growth Rate (2015-2020)Figure Europe Psoriasis Sales and Growth Rate (2015-2020)Figure Asia-Pacific Psoriasis Sales and Growth Rate (2015-2020)Figure Middle East and Africa Psoriasis Sales and Growth Rate (2015-2020)Figure South America Psoriasis Sales and Growth Rate (2015-2020)Figure North America Psoriasis Revenue ($) and Growth (2015-2020)Table North America Psoriasis Sales by Countries (2015-2020)Table North America Psoriasis Sales Market Share by Countries (2015-2020)Figure North America Psoriasis Sales Market Share by Countries in 2015Figure North America Psoriasis Sales Market Share by Countries in 2019Table North America Psoriasis Revenue ($) by Countries (2015-2020)Table North America Psoriasis Revenue Market Share by Countries (2015-2020)Figure North America Psoriasis Revenue Market Share by Countries in 2015Figure North America Psoriasis Revenue Market Share by Countries in 2019Figure United States Psoriasis Sales and Growth Rate (2015-2020)Figure Canada Psoriasis Sales and Growth Rate (2015-2020)Figure Mexico Psoriasis Sales and Growth (2015-2020)Figure Europe Psoriasis Revenue ($) Growth (2015-2020)Table Europe Psoriasis Sales by Countries (2015-2020)Table Europe Psoriasis Sales Market Share by Countries (2015-2020)Figure Europe Psoriasis Sales Market Share by Countries in 2015Figure Europe Psoriasis Sales Market Share by Countries in 2019Table Europe Psoriasis Revenue ($) by Countries (2015-2020)Table Europe Psoriasis Revenue Market Share by Countries (2015-2020)Figure Europe Psoriasis Revenue Market Share by Countries in 2015Figure Europe Psoriasis Revenue Market Share by Countries in 2019Figure Germany Psoriasis Sales and Growth Rate (2015-2020)Figure UK Psoriasis Sales and Growth Rate (2015-2020)Figure France Psoriasis Sales and Growth Rate (2015-2020)Figure Italy Psoriasis Sales and Growth Rate (2015-2020)Figure Spain Psoriasis Sales and Growth Rate (2015-2020)Figure Russia Psoriasis Sales and Growth Rate (2015-2020)Figure Asia-Pacific Psoriasis Revenue ($) and Growth (2015-2020)Table Asia-Pacific Psoriasis Sales by Countries (2015-2020)Table Asia-Pacific Psoriasis Sales Market Share by Countries (2015-2020)Figure Asia-Pacific Psoriasis Sales Market Share by Countries in 2015Figure Asia-Pacific Psoriasis Sales Market Share by Countries in 2019Table Asia-Pacific Psoriasis Revenue ($) by Countries (2015-2020)Table Asia-Pacific Psoriasis Revenue Market Share by Countries (2015-2020)Figure Asia-Pacific Psoriasis Revenue Market Share by Countries in 2015Figure Asia-Pacific Psoriasis Revenue Market Share by Countries in 2019Figure China Psoriasis Sales and Growth Rate (2015-2020)Figure Japan Psoriasis Sales and Growth Rate (2015-2020)Figure South Korea Psoriasis Sales and Growth Rate (2015-2020)Figure Australia Psoriasis Sales and Growth Rate (2015-2020)Figure India Psoriasis Sales and Growth Rate (2015-2020)Figure Southeast Asia Psoriasis Sales and Growth Rate (2015-2020)Figure Middle East and Africa Psoriasis Revenue ($) and Growth (2015-2020) continued

About HongChun Research:HongChun Research main aim is to assist our clients in order to give a detailed perspective on the current market trends and build long-lasting connections with our clientele. Our studies are designed to provide solid quantitative facts combined with strategic industrial insights that are acquired from proprietary sources and an in-house model.

Contact Details:Jennifer GrayManager Global Sales+ 852 8170 0792[emailprotected]

NOTE: Our report does take into account the impact of coronavirus pandemic and dedicates qualitative as well as quantitative sections of information within the report that emphasizes the impact of COVID-19.

As this pandemic is ongoing and leading to dynamic shifts in stocks and businesses worldwide, we take into account the current condition and forecast the market data taking into consideration the micro and macroeconomic factors that will be affected by the pandemic.

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Analyzing Impacts Of COVID-19 On Psoriasis Market Effects, Aftermath And Forecast To 2026 - Cole of Duty

The story so far: On July 11, pharma major Biocon announced that it had received the approval of the Drugs Controller General of India (DCGI) to market Itolizumab for treatment of cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome patients due to COVID-19. Itolizumab is a monoclonal antibody which is used to treat acute psoriasis.

Monoclonal antibodies are proteins cloned in the lab to mimic antibodies produced by the immune system to counter an infection. They have their genesis in serum, the colourless constituent of blood that contains antibodies. These proteins bind to an antigen, the fragment of an infectious virus in the case of SARS-CoV-2, and either destroy it or block its action. In the case of COVID-19, there are yet no proven drugs to treat moderate or severe manifestations of the disease. Among the therapies being tested is convalescent plasma, which is a constituent of blood and recovered from those who have successfully fought the disease. This blood contains antibodies produced within a week or two of being infected. While plasma therapy involves injecting this entire antibody-soup into another sick patient, a monoclonal antibody can be made by isolating specific antibodies and multiplying them via various techniques. Isolating plasma and serum is laborious and time-consuming when it must be administered to every patient. However, since 1975, several techniques have been perfected that allow antibodies once isolated to be easily replicated. These are stored in vials and can be injected into patients.

Also read | Biocons COVID-19 drug tested on too few patients to reliably conclude on benefits, say experts

While eight in 10 of those infected by the disease recover with little more than a few days of cough and fever, about one in 10 can manifest severe systems of the disease irrespective of their age and medical history. Experts are not sure why, but have observed that many who died were victims of a cytokine storm when the immune system goes into overdrive to flush out the virus. Pro-inflammatory cytokines recruit a host of specialised immune system cells to neutralise antigens. However, these cytokines can aggravate inflammation and injury in lung cells as well as in several other organs. A challenge in treatment is how to prevent this over-reaction. One method is to use antibodies that can block a particular protein, called CD6. They are found on the surface of T-cells, a class of cells that are a central prong in the bodys defence system.

Experts say if this CD-6 is suppressed, it will prevent the T-cells from releasing a cytokine cascade and thus better regulate the immune system. There is also a lot of research going on in using such antibodies to prevent the replication of the virus. Since last month there have been reports from laboratories from nearly everywhere, reporting the presence of one or more antibodies that could be used to block the spike protein, the key the coronavirus uses to infiltrate lung cells and proliferate. Before monoclonal antibodies were roped into discussions surrounding COVID-19, research has focused on deriving the right kind of antibodies that specifically bind onto regions of interest. These underpin the design of cancer therapies or fixes for autoimmune diseases, rheumatoid arthritis or acute psoriasis.

Sometimes antibodies are known to help viral entry and replication in target cells which can worsen the disease. This is why they need careful evaluation.

Also read | No evidence yet that itolizumab, tocilizumab reduces deaths: ICMR head

Itolizumab is an approved drug for acute psoriasis since 2013 and has passed safety and efficacy trials for that disease in over 500 patients. However, independent experts have pointed out that the efficacy of the drug in treating COVID-caused Acute Respiratory Disease Syndrome has not been conclusively demonstrated because it has, as part of a clinical trial, only been tested on 30 patients. However, the drug has been approved by the DCGI for emergency use in the treatment of moderate to severely-ill patients as per the discretion of physicians. The DCGI also directed Biocon to conduct a phase-4 study it must monitor it for adverse reactions or side-effects after it has been administered in large groups of patients and report back to the authorities. Experts pointed out that the normal process for approving a drug includes a phase-3 trial, where the drugs safety and efficacy are first evaluated in the wider population. Officials at Biocon claim they plan to test the drug in the United States, Canada, Australia and New Zealand. Several doctors, at a press conference organised by Biocon, said their patients had benefitted from the drug but mostly when they were yet to reach a stage before requiring ventilators or external oxygen support. The drug cost a little under 8,000 for every vial. Generally, four vials are necessary for treatment, company officials said.

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The Hindu Explains | Why is a psoriasis drug being used to treat COVID-19 patients? - The Hindu

This article was originally published here

Dermatol Ther. 2020 Jun 17:e13858. doi: 10.1111/dth.13858. Online ahead of print.

ABSTRACT

Coronavirus disease (COVID-19) is a highly contagious respiratory infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 outbreak has been declared a pandemic by the World Health Organization on March 2020. The pandemic has affected the management of psoriasis not only for those who are under treatment but also for those who are about to begin a new therapy to control their disease. An increasing number of studies in the current literature have focused on the relationship between psoriasis and COVID-19 from different perspectives. This narrative review includes searching the PubMed and Web of Science databases using the keywords psoriasis, psoriatic arthritis, coronavirus, COVID-19, and SARS-CoV-2. The search was supplemented by manual searching of reference lists of included articles. A total of 11 relevant original investigations and 6 case studies was identified. The search was updated in May 2019. Due to the absence of randomized controlled trials, it is not likely to have a robust evidence-based approach to psoriasis management in the era of COVID-19. However, the current literature may provide some clues for safety considerations. Conventional immunosuppressive therapies such as methotrexate and cyclosporine, and anti-tumor necrosis factor agents should not be preferred due to increased risk of infection, especially in high-risk areas. The use of cyclosporine may pose additional risk due to the side effect of hypertension, which has been reported to be associated with susceptibility to severe COVID-19. Considering that the current literature has provided no conclusive evidence that biologics increase the risk of COVID-19, withdrawal of these agents should be reserved for patients with COVID-19 symptoms. The treatment approach should be personalized, considering the advantages and disadvantages for each case separately.

PMID:32686245 | DOI:10.1111/dth.13858

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Psoriasis and COVID-19: A narrative review with treatment considerations - DocWire News

HELLERUP, Denmark, July 21, 2020 /PRNewswire/ -- UNION therapeutics A/S ("UNION") today announced the completion of a transaction with LEO Pharma A/S (LEO Pharma) to acquire the global rights for the LEO PDE4 inhibitor compound series to be re-named UNI500.

UNI500 is a series of phosphodiesterase type 4 (PDE4) inhibitors that were discovered by LEO Pharma. LEO Pharma has been developing candidates from this series from discovery into Phase 2 in psoriasis (orismilast, oral) and atopic dermatitis (orismilast, topical) and in both indications demonstrated superior effect over placebo in randomized, double-blinded, placebo-controlled clinical studies.

"The acquisition of the PDE4 inhibitor compound series is perfectly aligned with UNION's vision to build a sustainable pharmaceutical company and it complements our current clinical activities in immuno-dermatology. The acquisition substantially accelerates our growth trajectory and enables synergies at organizational, financial, and commercial levels. Above and beyond that, UNION considers compounds from the PDE4 inhibitor compound series to have best-in-class potential for the treatment of psoriasis and other immune-dermatological disorders, with an overarching aim to address unmet medical needs", said Rasmus Toft-Kehler, Chief Executive Officer of UNION.

Morten Sommer, Chief Scientific Officer, of UNION explains "Orismilast has demonstrated promising effects in clinical studies suggesting that it could become an attractive oral treatment option for patients with psoriasis and other immune-dermatological disorders. Our ambition, based on demonstrated potency levels, is to develop orismilast as a best-in-class PDE4 inhibitor across multiple immune-related diseases. As a next step, UNION will finalize formulation efforts with orismilast and simultaneously evaluate priority indications for clinical advancement".

Thorsten Thormann, Vice President, Global Research at LEO Pharma added "LEO Pharma has been working very closely with the UNION team and have been impressed with their approach and professionalism in dermatological drug development. Accordingly, when the strategic decision was taken to divest the LEO PDE4 inhibitor compound series and orismilast, UNION was an obvious partner of choice for LEO Pharma. We look forward to seeing the program moving forward for the benefit of patients in need of new treatment options".

Under the agreement, UNION will pay upfront, development and commercial milestones of up to 200 million USD, plus low single-digit royalties on sales. As part of the transaction, LEO Pharma also becomes a minority shareholder in UNION therapeutics.

About UNION therapeutics A/SUNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The company is working on two complementary chemistry classes spanning immunology and microbiology and has three candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced team across Europe and USA.

About LEO Pharma A/SThe company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries.

ContactsMorten BoesenChief Financial OfficerTel: +45 2381 5487Email: info@uniontherapeutics.com

JW CommunicationsJulia WilsonTel: +44 781 8430877Email: communications@uniontherapeutics.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/union-therapeutics/r/union-therapeutics-announces-acquisition-of-pde4i-compound-class-from-leo-pharma-with-oral-lead-cand,c3157569

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SOURCE UNION therapeutics

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UNION therapeutics announces acquisition of PDE4i compound class from LEO Pharma with oral lead candidate (orismilast) in Phase 2 - BioSpace

Written by Anuradha Mascarenhas | Pune | Updated: July 21, 2020 7:33:30 am The approval from the DCGI is based on the results from the conclusion of a randomised, controlled clinical trial at hospitals in Mumbai and New Delhi. (Express Photo/Praveen Khanna)

A repurposed drug, Itolizumab, is one of the newest treatments for Covid-19 approved in India. The Drug Controller General of India recently approved it as a novel biologic therapy for restricted emergency use. The decision has also sparked controversy because of the small size of the clinical trials, and because exemption has been granted from phase-III trials.

Itolizumab is an existing drug used for psoriasis, a chronic skin disease involving unregulated growth of some skin cells that develop into red patches mostly on knees and elbows, but also on some other parts of the body. The drug, developed by Bengaluru-based Biocon, was approved in 2013. It is considered safe and effective for the treatment of psoriasis.

Why was it approved for emergency use in Covid treatment?

The SARS-CoV-2 virus has been observed to induce an overreaction of the immune system, generating a large number of cytokines that can cause severe damage to the lungs and other organs, and, in the worst scenario, multi-organ failure and even death.

The approval from the DCGI is based on the results from the conclusion of a randomised, controlled clinical trial at hospitals in Mumbai and New Delhi. The study focused on the safety and efficacy of Itolizumab in preventing cardio-renal complications in Covid-19 patients who also have acute respiratory distress. The drug has been found to reduce these complications in such patients.

Also in Explained | Why community transmission no longer matters at this stage

Basically, the drug controls the hyper-activation of the immune system in response to SARS-CoV-2 virus and prevents morbidity and mortality related to the cytokine storm. The clinical trial showed that the drug is best administered in the pulmonary phase of the Covid-19 infection when the cytokine build up is starting and the patient is experiencing shortness of breath and exhibiting abnormal chest images. It prevents progression to the hyperinflammation phase (cytokine storm) and other complications like coagulation and organ failure, according to Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics.

The drug has been used over 80 patients in Cuba and off-label in over 150 cases. According to Dr Shashank Joshi, Dean, Indian College of Physicians, the most critical part is to know when to use the drug and it must be reserved for moderate to severe Covid cases with cytokine storm where oxygen requirements are rapidly going up. usually between the 8th day onwards of Covid infection.

What were the results of the trial?

The trial results showed a statistically significant advantage over the control group of patients, in one-month mortality rate. All the patients who were administered Itolizumab were weaned off oxygen by Day 30, and none needed ventilator support unlike the control group that did not get the drug. Some other inflammations commonly found in such patients were also suppressed, and these correlated well with clinical improvement in symptoms. Overall, the drug was found well-tolerated.

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How large was the trial?

The trial had 20 participants given the drug along with supportive care and 10 others given only supportive care. All 20 patients on Itolizumab recovered while three of the other 10 patients died.

Public health experts and some doctors have used social media to question the sample size of the trial. When journalists raised this question at a virtual press conference, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said Itolizumab has been approved in India and since the country is in a medical emergency, it was decided to go ahead with a clinical trial involving a cohort of 30 patients. She said the regulatory process was extremely robust and the scientific discussions on the trial was of a very high order.

The DCGI has also exempted the drug from phase III clinical trials and allowed phase IV trials (post-marketing surveillance). Itolizumab is not a new drug and was approved in India since 2013. We had done phase II and III trials, and got the approval. In the past seven years, its been used in psoriasis and we know how the mechanism works Biocon Biologics CMO Dr Athalye said. Company officials said they plan phase IV trials soon.

How much does it cost?

Each injection is presented as a 25mg/5ml solution, which costs Rs 7,950 per vial. Based on an average body weight of 60 kg, the therapy cost of a single dose comprising four vials is estimated at Rs 32,000 (MRP).

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Explained: What is Itolizumab, newly cleared for Covid-19? - The Indian Express