Positive news flowed in for Novartis AG (NVS) when the European Commission approved its biologic Cosentyx (secukinumab) for the first-line treatment of moderate-to-severe plaque psoriasis in adults who need systemic therapy.
Cosentyx (300 mg) is the first and only interleukin-17A (IL-17A) inhibitor to be approved in Europe. The current biologic treatments for psoriasis, that include anti-tumor necrosis factor therapies (anti-TNFs) and Janssen Biotech’s, a unit of Johnson & Johnson (JNJ), Stelara (ustekinumab), are recommended for second-line systemic therapy in Europe.
We note that results from the phase IIIb study CLEAR showed Cosentyx to be superior to Stelara in clearing the skin of patients suffering from moderate-to-severe plaque psoriasis. Moreover, Cosentyx showed superiority to Amgen Inc.’s (AMGN) Enbrel (etanercept) in clearing skin in the FIXTURE study.
Cosentyx is 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.
Meanwhile, 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 and psoriatic arthritis. Regulatory applications for these indications are planned in 2015.
The approval of Cosentyx in Europe 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 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.
Novartis currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the broader health care sector include Abbvie Inc. (ABBV), carrying a Zacks Rank #2 (Buy).
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