Novartis AG Psoriasis Drug Secukinumab Benefits Outweighs Risk: FDA Staff

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations


October 17, 2014

By Riley McDermid, BioSpace.com Breaking News Staff

Closely watched biotech Novartis AG has gotten the green light from the U.S. Food and Drug Administration for its new psoriasis drug secukinumab, staff reviewers on a panel told Reuters Friday.

The immunosuppressant is an IL-17 inhibitor that targets the protein interleukin-17 (IL-17), which causes inflammation and plays a primary role in the development of psoriasis. In clinical studies, over half of patients who received the drugs saw a 90 percent reduction in skin scaling, redness and thickness.

Those statistics had many analysts predicting a price war with competing psoriasis drug Enbrel, developed by Amgen , which only reduced symptoms in psoriasis patients by 21 percent.

The FDA will likely follow the recommendations of the panel and issue a formal approval later this fall.IL-17 is also an injectable biologic, which means it is grown in labs from already living cells. Its efficacy and ease of use could make it a major player in a market Citigroup analysts have said could skyrocket from $3.6 billion in 2012 to $7.6 billion by 2022 from.

Other competitors include Johnson & Johnson ‘s Stelara and Eli Lilly ‘s ixekizumab, while Amgen Inc has teamed up with AstraZeneca Plc reported in May on a separate anti-IL-17 drug, brodalumab.

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