Roche Holding AG said the U.S. Food and Drug Administration accepted its application for the expanded use of Xolair in treating nasal polyps.
The supplemental biologics license application is seeking approval for Xolair to treat nasal polyps in adult patients 18 years old and above who had inadequate response to intranasal corticosteroids.
Nasal polyps are soft, painless, noncancerous growths on the lining of nasal passages or sinuses. The condition affects 13 million people in the U.S.
The application is backed by results of two late-stage studies Polyp 1 and Polyp 2, in which Xolair met the main and secondary goals of improving both nasal polyps and nasal congestion in patients with a condition called chronic rhinosinusitis, which causes nasal obstruction.
The U.S. regulator is expected to make a decision on Xolair's approval by the third quarter of 2020.
Xolair is already approved to treat certain patients with asthma and chronic idiopathic urticaria, also known as hives. The drug is also approved in China for treating moderate to severe persistent allergic asthma.
Roche, through its Genentech Inc. unit, and Novartis AG are jointly developing and promoting Xolair in the U.S.