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FDA Accepts Sanofi's (SNY) sBLA for Dupixent in Pediatric EoE

Sanofi SNY and Regeneron REGN announced that the FDA had accepted a supplemental Biologics License Application (“sBLA”) seeking label expansion for their blockbuster drug Dupixent (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (“EoE”).

The agency has granted priority review to this filing and a final decision is expected by Jan 31, 2024. Dupixent will be the first and only FDA-approved treatment for EoE in children of this age group if approved.

Last year in May, Sanofi/Regeneron’s Dupixent received FDA approval for treating EoE in individuals aged 12 years and older. Following this approval, the drug became the first-ever approved treatment in this indication.

The sBLA filing is based on data from the phase III EoE KIDS study, which evaluated Dupixent in children aged 1 to 11 years with EoE. The study achieved its primary endpoint of histological disease remission following 16 weeks of treatment with the drug. Data from the study also showed that treatment with Dupixent maintained histologic remission for 52 weeks, a secondary endpoint. The drug is yet to be approved anywhere for treating EoE in children aged under 12 years.

Shares of Sanofi have risen 12.2% in the year compared with the industry’s 5.7% growth.

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Regeneron’s stock has gained 15.7% year to date against the industry’s 16.1% decline.

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A blockbuster drug, Dupixent is a key topline driver for Sanofi and Regeneron. Apart from EoE, the drug is currently approved in the United States and Europe for four other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, and prurigo nodularis. With outside U.S. revenues accelerating and multiple approvals for new indications and expansion in younger patient populations expected, its sales are likely to be higher.

In first-half 2023, Sanofi recorded €4.9 billion (around $5.3 billion) from Dupixent product sales, indicating a 36.7% year over year growth. Sanofi expects Dupixent to achieve more than €13 billion in peak sales and €10 billion in 2023.

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 drug’s global sales. Both companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic spontaneous urticaria.

Like Sanofi/Regeneron, many large-cap pharma giants like Bristol Myers BMY and Pfizer PFE are also developing their own pipeline candidates for treating EoE.

Bristol Myers is currently evaluating its investigational IL-13 inhibitor, cendakimab, for treatment of EoE in a phase III registrational study. Pfizer is also evaluating its oral S1P modulator etrasimod in a mid-stage study to treat EoE. However, both the Bristol Myers and Pfizer candidates are still at least a couple of years away from regulatory approval and potential commercialization, which is likely to provide Dupixent with an edge in the EoE indication.

Sanofi Price


Sanofi Price
Sanofi Price

Sanofi price | Sanofi Quote


Regeneron Pharmaceuticals, Inc. Price


Regeneron Pharmaceuticals, Inc. Price
Regeneron Pharmaceuticals, Inc. Price

Regeneron Pharmaceuticals, Inc. price | Regeneron Pharmaceuticals, Inc. Quote


Zacks Rank

Sanofi and Regeneron currently carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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