Regeneron, Sanofi Get FDA Approval for Upper Airway Disease Treatment

By Connor Hart

Regeneron Pharmaceuticals and Sanofi have received Food and Drug Administration approval for their treatment of an inflammatory condition that affects the sinuses and nasal passages in adolescents, the companies said.

The treatment, called Dupixent, has been approved as an add-on maintenance treatment for patients 12- to 17-years-old with inadequately controlled chronic rhinosinusitis with nasal polyps, the healthcare companies said Friday.

Previously, the standard treatments for adolescents with the disease were systemic steroids and surgery.

This approval expands upon Dupixent's initial clearance from June 2019, when it received FDA approval for treatment of the disease for adults. Two trials in adults have shown significant improvements at 24 weeks compared with placebo, the companies said. The approval is also supported by safety data in adolescents ages 12 and up with moderate-to-severe asthma.

Regeneron President and Science Chief George Yancopoulos said that more than one million patients around the world are currently being treated with Dupixent. "We are pleased to bring the well-established efficacy and safety of Dupixent to the many children suffering from chronic rhinosinusitis with nasal polyps, which can make their breathing more laborious and difficult, and also deprive them of their sense of smell," he said.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

September 13, 2024 13:04 ET (17:04 GMT)

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