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Roche: FDA approves application for Xolair

(CercleFinance.com) - Roche announces that the FDA has approved its supplemental Biologics License Application for Xolair (omalizumab), a prefilled syringe for self-injection in all approved indications in the US.


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

In the US, Roche's subsidiary Genentech and Novartis Pharmaceuticals are working together to develop and jointly promote Xolair. Approximately 460,000 patients have been treated in the country with Xolair since its initial approval in 2003.


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