Novartis (NVS) announced that the FDA has approved Cosentyx for the treatment of moderate-to-severe plaque psoriasis in adult patients who require systemic therapy or phototherapy (light therapy).
Cosentyx is the first approved human monoclonal antibody that selectively binds to interleukin IL-17A.
The FDA approval was based on the positive efficacy and safety outcomes from 10 phase II and phase III studies wherein it was observed that Cosentyx resulted in clear or almost clear skin in majority of the patients. Cosentyx (300 mg) also maintained its safety profile when compared to Amgen Inc.’s (AMGN) Enbrel (etanercept) and Janssen Biotech’s, a unit of Johnson & Johnson (JNJ), Stelara (ustekinumab).
We remind investors that the approval was on the cards as the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee had unanimously voted in favor of approving Cosentyx in Oct 2014.
Earlier in the week, Cosentyx was approved in the EU as well for the same indication. Cosentyx is already approved in Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Novartis is also evaluating Cosentyx for the treatment of ankylosing spondylitis and psoriatic arthritis. Regulatory applications for these indications are scheduled in 2015.
The approval of Cosentyx in the U.S. and Europe will be a boost for Novartis as it will further strengthen the company’s dermatology portfolio. The company already has Xolair in its dermatology portfolio, which is approved in both the EU and the U.S. While the treatment is labeled as refractory chronic spontaneous urticaria in the EU, it is known as refractory chronic idiopathic urticaria in the U.S.
Successful development and commercialization of its pipeline is important for Novartis as it faces generic competition for several key drugs such as Gleevec, Zometa and Diovan.
Meanwhile, last week, Celgene Corporation (CELG) also gained EU approval for Otezla for psoriatic arthritis and psoriasis. Otezla was approved in the U.S. in Mar 2014.
Novartis currently carries a Zacks Rank #3 (Hold). Both Celegene and Amgen are currently well placed with a Zacks Rank #1 (Strong Buy).
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