Category Archives: Transhuman News

The Novartis headquarters in Basel, Switzerland.

ZURICH--Swiss pharmaceutical company Novartis AG said Friday that it won approval in Japan for a new psoriasis drug, the first country to give the treatment a green light for commercialization.

Novartis NOVN, -1.28% said secukinumab, marketed as Cosentyx, is approved in the country to treat psoriasis vulgaris and psoriatic arthritis in patients who dont respond to other medication.

The drug is seen by some analysts as a potential blockbuster, industry jargon for medicines that generate more than $1 billion in sales annually. Demand for new treatments for psoriasis and related diseases is high.

Psoriasis is a chronic disease that is characterized by thick and extensive skin lesions. It causes itching, scaling and pain. Psoriatic arthritis causes joint pain, stiffness and irreversible joint damage.

Cosentyx inhibits the action of a protein found in high concentrations in skin affected by psoriasis, Novartis said.

An expanded version of this report appears at WSJ.com.

Continue reading here:
The Wall Street Journal: Novartis psoriasis drug approved in Japan

Swiss pharmaceutical giant Novartis AG (NVS: Quote) said Friday that Cosentyx has been approved in Japan for both psoriasis vulgaris and psoriatic arthritis, marking the first country approval for Cosentyx in the world. The approval also makes Cosentyx the first interleukin-17A or IL-17A inhibitor to receive regulatory approval in either of these indications in Japan.

Novartis said that the Japanese Ministry of Health, Labour and Welfare approved Cosentyx or secukinumab, formerly known as AIN457, for the treatment of both psoriasis vulgaris and psoriatic arthritis or PsA in adults who are not adequately responding to systemic therapies.

David Epstein, Division Head, Novartis Pharmaceuticals said, "We are pleased that Japan is the first country to approve Cosentyx for both psoriasis and psoriatic arthritis, providing an alternative treatment option for more than 400,000 Japanese citizens who are living with psoriasis, and those also living with psoriatic arthritis."

Psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions, called plaques. The plaques are known to cause itching, scaling and pain, and is associated with significant impairment of physical and psychological quality of life.

Closely linked with psoriasis, PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage. Psoriatic arthritis affects 30 percent of psoriasis patients globally and can cause irreversible joint damage.

Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis and central to the development of inflammatory diseases, including psoriasis and PsA.

Novartis noted that many patients do not respond to or tolerate current psoriasis or psoriatic arthritis treatments, indicating an unmet need for new therapies for these diseases. The company noted that with today's approval, these patients now have a new treatment option that effectively treats both diseases.

The Japanese approval was based on the safety and efficacy results from more than 10 Phase II and Phase III studies, which included nearly 4,000 patients with moderate-to-severe plaque psoriasis.

It was also supported by two pivotal Phase III studies, FUTURE 1 and FUTURE 2, involving more than 1,000 patients with PsA. In all studies, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events between Cosentyx treatment arms of 300 mg and 150 mg.

Novartis obtained a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP in November 2014, recommending Cosentyx as a first-line treatment of moderate-to-severe psoriasis patients in Europe.

Read more here:
Novartis Psoriasis Drug Approved In Japan

By RTT News, December 26, 2014, 07:22:00 AM EDT

(RTTNews.com) - Swiss pharmaceutical giant Novartis AG ( NVS ) said Friday that Cosentyx has been approved in Japan for both psoriasis vulgaris and psoriatic arthritis, marking the first country approval for Cosentyx in the world. The approval also makes Cosentyx the first interleukin-17A or IL-17A inhibitor to receive regulatory approval in either of these indications in Japan.

Novartis said that the Japanese Ministry of Health, Labour and Welfare approved Cosentyx or secukinumab, formerly known as AIN457, for the treatment of both psoriasis vulgaris and psoriatic arthritis or PsA in adults who are not adequately responding to systemic therapies.

David Epstein, Division Head, Novartis Pharmaceuticals said, "We are pleased that Japan is the first country to approve Cosentyx for both psoriasis and psoriatic arthritis, providing an alternative treatment option for more than 400,000 Japanese citizens who are living with psoriasis, and those also living with psoriatic arthritis."

Psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions, called plaques. The plaques are known to cause itching, scaling and pain, and is associated with significant impairment of physical and psychological quality of life.

Closely linked with psoriasis, PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage. Psoriatic arthritis affects 30 percent of psoriasis patients globally and can cause irreversible joint damage.

Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis and central to the development of inflammatory diseases, including psoriasis and PsA.

Novartis noted that many patients do not respond to or tolerate current psoriasis or psoriatic arthritis treatments, indicating an unmet need for new therapies for these diseases. The company noted that with today's approval, these patients now have a new treatment option that effectively treats both diseases.

The Japanese approval was based on the safety and efficacy results from more than 10 Phase II and Phase III studies, which included nearly 4,000 patients with moderate-to-severe plaque psoriasis.

It was also supported by two pivotal Phase III studies, FUTURE 1 and FUTURE 2, involving more than 1,000 patients with PsA. In all studies, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events between Cosentyx treatment arms of 300 mg and 150 mg.

Originally posted here:
Novartis Drug Cosentyx Approved In Japan For Psoriasis And Psoriatic Arthritis

By RTT News, December 26, 2014, 02:39:00 AM EDT

(RTTNews.com) - Novartis ( NVS ) said Friday that the Japanese Ministry of Health, Labour and Welfare or MHLW approved Cosentyx (secukinumab, formerly known as AIN457), for the treatment of both psoriasis vulgaris and psoriatic arthritis or PsA in adults who are not adequately responding to systemic therapies (except for biologics).

The company noted that the approval marks the first country approval for Cosentyx in the world and makes it the first interleukin-17A or IL-17A inhibitor to receive regulatory approval in either of these indications in Japan.

The approval was based on the safety and efficacy results from more than 10 Phase II and Phase III studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis and supported by two pivotal Phase III studies, FUTURE 1 and FUTURE 2, involving more than 1,000 patients with PsA.

In all studies, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events or AEs between Cosentyx treatment arms (300 mg and 150 mg).

Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis and central to the development of inflammatory diseases, including psoriasis and PsA. As approximately 30% of psoriasis patients are also affected by PsA globally.

Psoriatic arthritis is a debilitating, long-lasting inflammatory disease linked with significant disability, poor quality of life and reduced life expectancy.

The company said that the US Food and Drug Administration approval in the same indication is anticipated in early 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.

For comments and feedback: contact editorial@rttnews.com

http://www.rttnews.com

Read the original here:
Novartis'' Cosentyx Approved In Japan For Both Psoriasis And Psoriatic Arthritis