Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and, finally, a response from the regulatory agency regarding the approval status.
Earlier this week, Eli Lilly and Company LLY gained FDA approval for its psoriasis treatment, Taltz. Taltz is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
Taltz works by specifically targeting IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis. However, Taltz is not the first IL-17A antagonist to gain FDA approval. Novartis NVS has a head start with its IL-17A antagonist, Cosentyx, gaining FDA approval last year in January. Since then, the Cosentyx label has been expanded to include two additional indications – active ankylosing spondylitis and active psoriatic arthritis. Cosentyx brought in total sales of $261 million last year.
Meanwhile, Lilly intends to launch Taltz in the second quarter. Even though several treatments are available, the psoriasis market represents huge commercial potential. As per the National Psoriasis Foundation, about 7.5 million Americans suffering from the ailment and the American Academy of Dermatology estimates that about 20% of these patients have moderate-to-severe plaque psoriasis.
EU approval should also come shortly for Taltz with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion last month. Lilly plans to pursue psoriatic arthritis and ankylosing spondylitis indications for Taltz as well.
Lilly is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Actelion Ltd. ALIOF and Johnson & Johnson JNJ. While Actelion is a Zacks Rank #1 (Strong Buy) stock, Johnson & Johnson is a Zacks Rank #2 (Buy) stock.
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