TARRYTOWN, N.Y. - The U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab), as disclosed by Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EPA:SASY) (NASDAQ:SNY). This review is for Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), a condition characterized by sinus and nasal passage obstruction that can lead to a loss of smell.
The FDA's target action date for a decision on Dupixent's expanded use is September 15, 2024. If approved, Dupixent would become the first treatment in the U.S. for this age group with inadequately controlled CRSwNP. Currently, Dupixent is approved for use in adults with the same condition.
The sBLA submission is based on extrapolated efficacy data from two adult trials, SINUS-24 and SINUS-52, which demonstrated that Dupixent significantly improved nasal congestion/obstruction severity, nasal polyp size, and sense of smell. Additionally, it reduced the need for systemic corticosteroids or surgery in adults at 24 weeks compared to a placebo. The safety data supporting the application comes from the drug's currently approved indications for adolescents.
In the trials, adverse events more commonly observed with Dupixent compared to placebo included injection site reactions and arthralgia. The safety profile in these studies was generally consistent with the known safety profile of Dupixent in its approved indications.
Priority Review designation is given to drugs that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. CRSwNP is often associated with type 2 inflammation and can lead to various complications, including breathing difficulties and reduced quality of life. Many patients also suffer from co-morbid type 2 inflammatory diseases like asthma, which can exacerbate their symptoms.
Dupixent, developed using Regeneron's proprietary VelocImmune® technology, inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways but is not an immunosuppressant. It has been approved in over 60 countries for various indications and is currently being used to treat more than 850,000 patients worldwide.
Regeneron and Sanofi are also investigating Dupixent for other conditions driven by type 2 inflammation or allergic processes in ongoing clinical trials. However, the safety and efficacy of Dupixent for these potential uses have not been fully evaluated by any regulatory authority.
This article is based on a press release statement.
InvestingPro Insights
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) is at the forefront of innovation with its recent FDA Priority Review for Dupixent® in adolescents. As the company aims to expand its treatment offerings, investors and industry watchers are closely monitoring Regeneron's financial health and market performance. Here's a snapshot of the company's recent data and strategic moves:
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