Sanofi's Dupixent Gets FDA Approval for Eczema in Children

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Sanofi SNY announced that the FDA has approved its blockbuster medicine Dupixent for treating children (aged between six and 11 years) with moderate-to-severe atopic dermatitis (AD) or eczema whose disease is not adequately controlled with topical prescription therapies. Following this nod, the drug became the first and the only biologic medicine to be approved for the given patient population.

Dupixent is being jointly marketed by Sanofi and Regeneron REGN under a global collaboration agreement. The medicine is already approved to treat moderate-to-severe atopic dermatitis in adults as well as two other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis and severe asthma in both the United States and Europe.

The FDA approval is based on the results of a pivotal phase III study, evaluating efficacy and safety of Dupixent combined with topical corticosteroids (TCS) in children with severe AD. The data showed that children treated with Dupixent and TCS experienced significantly improved overall disease severity, skin clearing and itching compared to TCS alone.

Moreover, three-quarters of patients who were treated with Dupixent achieved at least a 75% improvement in overall disease with average improvement of approximately 80%.

The supplemental biologics license application (sBLA) seeking approval for Dupixent to treat eczema in children was accepted by the FDA for a Priority Review in January 2020.The FDA previously granted a Breakthrough Therapy designation to Dupixent for the same indication.

Shares of Sanofi have decreased 5.9% so far this year compared with the industry’s decline of 2.6%.


Dupixent generated sales of €776 million in the first quarter of 2020, up 129.8% year over year. Sales of the drug in the United States were €613 million, up 123.7%, driven by continued growth in AD and a rapid uptake for new asthma indication besides its launch for chronic rhinosinusitis with nasal polyposis in June 2019.

The frequent label expansion approvals are driving the drug’s sales higher with the momentum expected to continue in the future quarters as well.

Zacks Rank & Other Stocks to Consider

Sanofi currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the large cap pharma sector include Eli Lilly and Company LLY and AbbVie Inc. ABBV, both sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Eli Lilly’s earnings have been revised 0.6% upward for 2020 and 1.1% for 2021 over the past 60 days. The stock has gained 12.6% year to date.

AbbVie’s earnings have been revised 14.2% upward for 2020 and 6.6% for 2021 over the past 60 days. The stock has inched up 2.4% year to date.

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