FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease

On Friday, the FDA accepted for review the resubmission of the supplemental biologics license application (sBLA) for Regeneron Pharmaceuticals, Inc. REGN and Sanofi SA’s SNY Dupixent (dupilumab) for patients ages 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.

The target action date for the FDA decision is April 18, 2025.

Data from the multi-study LIBERTY-CUPID phase 3 clinical program (Study A, Study B, and Study C) for Dupixent in CSU support the resubmitted supplemental marketing.

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Earlier this year, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A.

The supplemental marketing adds results from Study C, conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second LIBERTY-CUPID pivotal study in biologic-naïve patients, met its primary and key secondary endpoints, confirming the results of the previous Study A.

Results showed that Dupixent significantly reduced itch and urticaria activity (itch and hives).

In March 2023, the FDA accepted the supplemental marketing application for Dupixent (dupilumab) to treat adults and adolescents with chronic spontaneous urticaria, with the target action date for the FDA decision of October 22, 2023.

In October 2023, the FDA issued a Complete Response Letter for the supplemental Biologics License Application and stated that additional efficacy data are required to support approval.

It did not identify any issues with safety or manufacturing.

CSU is a chronic inflammatory skin disease driven partly by type-2 inflammation, which causes sudden hives and recurring itch.

CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control urticaria symptoms.

More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.

Price Action: REGN stock closed at $782.51 on Thursday, and SNY stock is up 1.09% at $48.34 during the premarket session at last check Friday.

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