Sanofi SNY and partner Regeneron REGN announced that the FDA has approved its blockbuster medicine Dupixent (dupilumab) for a new indication — moderate-to-severe atopic dermatitis (AD) or eczema in children aged six months to five years.
Please note that Sanofi and Regeneron had already received approval for Dupixent for treating adults with moderate-to-severe AD in 2017. This was the first FDA-approved indication for the drug.
Following the recent label expansion in children, Dupixent has become the first-and-only-approved biologic medicine to treat moderate-to-severe AD from infancy to adulthood.
This is the second label expansion for Dupixent in the United States this year. Last month, the FDA approved a label expansion application from Sanofi and Regeneron for Dupixent to include adults and children aged 12 and older with eosinophilic esophagitis. Dupixent is also approved as an add-on maintenance treatment for moderate-to-severe asthma in patients aged 6 years or older and for inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults.
Sanofi and Regeneron’s other regulatory application for Dupixent seeking label expansion to include adult patients with uncontrolled prurigo nodularis was accepted by the FDA and granted priority review last month. A regulatory decision is expected in September.
The recent label expansion of Dupixent in pediatric patients with AD is supported by data from the phase III study evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS). Data from the study showed that Dupixent plus TCS significantly improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to TCS alone.
Sanofi stock has risen 7.1% this year so far compared with the industry’s increase of 3.7%.
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Dupixent is being jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent while Regeneron records its share of profits/losses in connection with the global sales of the drug.
Dupixent sales are now annualizing at close to €6.0 billion after around three years on the market. Sanofi expects Dupixent to achieve more than €13 billion in peak sales. The drug’s frequent label expansion approvals are driving sales higher.
Apart from the United States, Dupixent is also approved for treating certain patients with asthma, specific patients with moderate-to-severe AD as well as CRSwNP in different age populations in Europe, Japan and other countries. Dupixent is under review in Europe for eosinophilic esophagitis.
Sanofi and Regeneron are also studying dupilumab in late-stage studies in a broad range of diseases, driven by type II inflammation like pediatric eosinophilic esophagitis, chronic obstructive pulmonary disease, urticaria, and bullous pemphigoid.
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Zacks Rank & Stocks to Consider
Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A couple of better-ranked biotech stocks are Alkermes ALKS and Sesen Bio SESN. While Alkermes sports a Zacks Rank #1, Sesen carries a Zacks Rank #2 (Buy).
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 14 cents to 3 cents in the past 60 days. Shares of ALKS have risen 24.5% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.48%.
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has narrowed from 33 cents to 32 cents per share in the past 60 days. Shares of SESN have declined 16.6% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.94%.
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