Sanofi ( SNY Quick Quote SNY - Free Report) and partner Regeneron Pharmaceuticals, Inc. REGN announced that the FDA has granted priority review to a regulatory filing looking for label expansion of Dupixent for inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). With the FDA granting priority review, a decision is expected on Jun 26.
Dupixent is already marketed for two allergic inflammatory diseases in the United States, atopic dermatitis (eczema) and moderate-to-severe asthma.
The supplemental biologics license application (sBLA) was looking for approval of Dupixent as an add-on maintenance treatment for adults with CRSwNP. No medicines are presently approved to treat this chronic disease. The sBLA filing was based on data from two pivotal phase III studies, which evaluated Dupixent plus standard-of-care corticosteroid nasal spray in patients who have experienced recurrence of their disease despite previous treatment with surgery and/or systemic corticosteroids.
Top-line data from the two phase III studies were presented in October last year. The study met all the primary and secondary endpoints. The data showed that treatment with Dupixent led to a significant reduction in nasal polyp size, nasal congestion severity and the need for systemic corticosteroids and/or surgery.
Dupixent coupled with another new drug Kevzara, approved to treat rheumatoid arthritis (RA), is part of Sanofi’s new immunology franchise. Sales of the immunology franchise are annualizing at well over €1 billion after less than two years in the market driven mainly by Dupixent.
Dupixent generated sales of $922 million in 2018. Dupixent is also being studied in pediatric and adolescent atopic dermatitis, pediatric asthma, eosinophilic esophagitis (phase II/III) and food and environmental allergies (phase II). We are optimistic about sales prospects of Dupixent, which could prove to be an important growth driver for the company.
Sanofi’s shares have underperformed the
industry this year so far. It has declined 1.1% in the said time frame against a 2.1% increase for the industry.
Sanofi currently carries a Zacks Rank #3 (Hold). Better-ranked large-cap pharma stocks are AstraZeneca
AZN and Bayer BAYRY, carrying a Zacks Rank #2 (Buy).
Shares of AstraZeneca have risen 9.9% this year so far while earnings estimates for 2019 have risen 5.3% while that for 2020 have gone up almost 1% in the past 30 days.
Bayer’s stock is up 11.2% this year. Estimates for 2019 have risen 1.6% in the past 30 days.
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