Novartis' Psoriasis Drug Cosentyx Backed for EU Approval
Novartis AG (NVS) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion on the approval of Cosentyx (secukinumab, formerly known as AIN457). Cosentyx is the first IL-17A inhibitor to be recommended as a first-line treatment option for psoriasis patients who require systemic therapy in Europe.
Cosentyx works by inhibiting IL-17A, a protein that is found in high concentrations in skin affected by the disease.
The CHMP’s favorable opinion comes shortly after Cosentyx received a unanimous recommendation from the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (:DODAC) last month -- a final decision from the FDA should be out in early 2015. The favorable opinion of the CHMP will now be reviewed by the European Commission with a final decision expected in the next couple of months.
With the CHMP in favor of approving Cosentyx, we believe chances of approval are high. Once approved, Cosentyx will be entering an extremely crowded psoriasis market given the presence of products like Stelara, Enbrel and Otezla.
Moreover, new treatments are currently in development including Amgen (AMGN)/AstraZeneca’s (AZN) brodalumab.
However, with Cosentyx consistently demonstrating very high skin clearance, including superiority to Enbrel in the head-to-head FIXTURE study, and given the high rate of dissatisfaction among patients regarding existing treatment options, Cosentyx could rapidly gain share once approved.
Meanwhile, Novartis is evaluating Cosentyx for several other indications including ankylosing spondylitis and psoriatic arthritis among others.
Novartis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Allergan Inc. (AGN) carrying a Zacks Rank #1 (Strong Buy).
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