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FDA Approves Roche's Xolair Prefilled Syringe For Self-Injection Across All Indications

Roche (RHHBY) said Tuesday that it has received an approval from the U.S. Food and Drug Administration for its supplemental Biologics License Application of Xolair or omalizumab prefilled syringe for self-injection across all approved U.S. indications.

Xolair is the FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps.

The company noted that appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the COVID-19 pandemic.

Xolair, which was first approved in the U.S. in 2003 to treat allergic asthma and is now also approved for chronic idiopathic urticaria and nasal polyps, previously required a healthcare professional administration.

In the U.S., Roche's Genentech and Novartis work together to develop and co-promote Xolair.

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