FDA approves Cosentyx for treatment of Plaque Psoriasis- Novartis

Novartis announced the FDA has approved Cosentyx (secukinumab) for the treatment of moderate-to-severe Plaque Psoriasis in adult patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy). Cosentyx is the first approved Psoriasis medication to selectively bind to IL-17A and inhibit interaction with the IL-17 receptor. The approval is based on the efficacy and safety outcomes from 10 Phase II and Phase III studies, including over 3,990 adult patients with moderate-to-severe Plaque Psoriasis, which demonstrated that Cosentyx resulted in clear or almost clear skin in the majority of patients and had an acceptable safety profile.

Comment:Some analysts expect that new Psoriasis treatments could double the market to more than $7 billion by 2022, with Eli Lilly , Amgen , Celgene and AstraZeneca/MedImmune in competition. An interesting late-stage program is for brodalimumab, another anti-IL-17 therapy a collaboration between Amgen and AstraZeneca. Cipla has begun launching a biosimilar to Enbrel (etanercept), while Novartis's Sandoz unit has a Phase III biosimilar under way as well.

Eli Lilly has ixekizumab an IL-17 receptor inhibitor which has showed promising results. Celgene has approval for Otezla, an oral drug, for Psoriasis and Psoriatic Arthritis and Merck has MK 3222 in development and Johnson & Johnson has guselkumab.

A recent survey showed that 52% of patients surveyed were dissatisfied with their disease management for Psoriasis.