FDA approves expanded label for Regeneron/Sanofi's Dupixent

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FDA approves expanded label for Regeneron/Sanofi's Dupixent
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The U.S. Food and Drug Administration on Wednesday approved Regeneron Pharmaceut...

- The U.S. Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals Inc and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.

The expanded label, which could significantly boost annual sales, is for use with other medicines to treat patients suffering from chronic rhinosinusitis with nasal polyps, the companies said in a joint statement. Chronic rhinosinusitis is a persistent inflammation of the mucous membranes in the nose and sinuses that can lead to development of nasal polyps - teardrop shaped, noncancerous growths that can cause irritation and swelling.

Cowen analyst Yaron Werber, citing the drug’s effectiveness and clean safety profile, forecast that the additional approval will add $956.3 million to Dupixent’s worldwide sales in 2024, calling it “a sizable but overlooked market with few entrenched competitors.”Data released earlier this month showed Roche AG and Novartis’ Xolair is able to treat patients with chronic rhinosinusitis with nasal polyps, potentially pitting it against Dupixent in this patient group.

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