AstraZeneca's Fasenra gets FDA rejection for expanded use in chronic rhinosinusitis
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The U.S. Food and Drug Administration rejected to approve the expanded use of AstraZeneca's (NASDAQ:AZN) asthma therapy Fasenra to treat patients with inadequately controlled chronic rhinosinusitis with nasal polyps.
The condition is characterized by persistent inflammation of the mucous membrane lining the nasal passages and sinus with benign growths, called nasal polyps.

The company said the FDA's complete response letter requested additional clinical data and it was working closely with the agency regarding the next steps.
The company added that its supplemental biologics license application included data from the OSTRO phase 3 trial, which met both co-primary goals with a safety profile consistent with the known profile of the drug.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the U.S., EU, Japan and certain other countries.
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