Novartis Wins U.S. Approval for First of New Psoriasis Drugs

Novartis AG (NOVN) won U.S. approval for the first in a new line of psoriasis drugs that aim to better treat the itchy, sometimes debilitating skin condition.

The Food and Drug Administration cleared the treatment to be called Cosentyx. The medicine, also known as secukinumab, is predicted to top $1 billion in sales by 2020 and will compete with other biologic drugs including AbbVie Inc. (ABBV)s No. 1 seller, Humira, and Amgen Inc. (AMGN)s best-selling Enbrel. The therapy was backed in November by European Commission health regulators.

About 7.5 million Americans have psoriasis, which is an autoimmune disease that can cause raised, red patches on the skin that are covered in dead skin cells, according to the National Psoriasis Foundation. The new type of drugs called interleukin inhibitors block interaction with the IL-17A receptor, which triggers the inflammatory response that plays a role in the disease, the FDA said.

The FDAs approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only approved treatment targeting the IL-17 pathway, David Epstein, division head of Novartis Pharmaceuticals, said in a statement.

Similar drugs are in development at Eli Lilly & Co. (LLY) and in a partnership of Amgen and AstraZeneca Plc. (AZN) The new therapies work faster and are expected to be more effective for the most serious patients.

Cosentyx is administered as an injection under the skin. It is intended for patients who are candidates for systemic therapy, treatment using substances that travel through the bloodstream, and ultraviolet light therapy, or a combination of both, the FDA said today in a statement.

The FDAs approval was based on four clinical trials that studied secukinumab against a placebo and found more patients on the drug had clear or almost clear skin, the agency said.

Novartis, based in Basel, Switzerland, also studied secukinumab against Thousand Oaks, California-based Amgens Enbrel and said it worked significantly better to clear the skin. The latest study pitting secukinumab against Johnson & Johnson (JNJ)s Stelara showed Novartiss drug worked better, the company said in a Dec. 12 statement.

Novartiss drug may generate $1.1 billion in annual sales in 2020, according to the average of seven analysts estimates compiled by Bloomberg. AbbVies Humira had an estimated $12.6 billion in sales in 2014 while Amgen and Pfizer Inc. are expected to report about $8.4 billion in Enbrel revenue.

Older treatments such as Enbrel and Humira block a protein called TNF that signals the body to create inflammation. Stelara targets proteins known as IL-12 and IL-23, while secukinumab goes after IL-17A, which only recently has been linked to psoriasis.

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Novartis Wins U.S. Approval for First of New Psoriasis Drugs