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Genentech: FDA Accepts SBLA For Xolair To Treat Nasal Polyps

Genentech, a member of Swiss drug maker Roche Group (RHHBY), announced Wednesday that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA for Xolair (omalizumab) to treat nasal polyps in adult patients.

The FDA is expected to make a decision on approval for this indication by the third quarter of fiscal 2020.

Once approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E or IgE.

The sBLA is based on results from the Phase III POLYP 1 and POLYP 2 trials, which showed Xolair met both co-primary and multiple secondary endpoints in treating adult patients with chronic rhinosinusitis with nasal polyps or CRSwNP who have not adequately responded to intranasal corticosteroids.

Nasal polyps is a common and potentially debilitating condition in adults, impacting 13 million people in the U.S. At present, limited treatment options are available, with many patients opting for nasal surgery or systemic steroids.

Xolair is an injectable biologic medicine designed to target and block IgE. Xolair is currently approved for the treatment of moderate to severe persistent allergic asthma in people six years of age or older. It is also approved for chronic idiopathic urticaria in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines.

In the U.S., Genentech and Novartis Pharmaceuticals Corp. work together to develop and co-promote Xolair.

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