Novartis (NVS) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Cosentyx (secukinumab) for the treatment of both psoriasis vulgaris and psoriatic arthritis (PsA) in adults who have failed to respond adequately to systemic therapies (except for biologics).
The approval was based on positive safety and efficacy results from more than 10 phase II and phase III studies and supported by two pivotal phase III studies, FUTURE 1 and FUTURE 2.
The studies demonstrated a favorable safety profile for Cosentyx, with similar incidence and severity of adverse events across the different treatment arms.
Meanwhile, Cosentyx has obtained a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). In Nov 2014, the CHMP recommended Cosentyx as a first-line treatment of moderate-to-severe psoriasis.
In Oct 2014, the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously voted in favor of approving Cosentyx for the treatment of moderate-to-severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy. The DODAC’s recommendation was based on safety and efficacy data from 10 phase II/III studies in patients suffering from moderate-to-severe plaque psoriasis.
A response from the FDA regarding the approval of Cosentyx should be out in early 2015.
Novartis is also evaluating Cosentyx for the treatment of ankylosing spondylitis (AS) and rheumatoid arthritis (RA).
The approval of Cosentyx in Japan will be a major 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 both in 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.
The successful development and commercialization of the pipeline is important for the company as it faces generic competition for several key drugs such as Gleevec, Zometa and Diovan.
Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader health care sector include AbbVie (ABBV), Allergan (AGN) and Abbott Inc (ABT). All three carry a Zacks Rank #2 (Buy).
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