Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair prefilled syringe.
South San Francisco-based Genentech touts the Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications as the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for treating moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps, according to a news release.
Use of Xolair requires no prior history of anaphylaxis beforehand and a user must be closely observed by a healthcare provider for at least three injections with no hypersensitivity. After Xolair therapy is initiated and safely established, a healthcare provider can determine if self-injection is appropriate.
Genentech said approximately 460,000 patients have been treated with Xolair in the U.S. since it was initially approved in 2003. The prefilled syringe is developed and co-promoted by Genentech and Novartis in the U.S.
“Today’s approval reflects our commitment to continued innovation with Xolair to address the critical needs of people living with allergic and inflammatory conditions,” Genentech CMO & head of global product development Dr. Levi Garraway said in the release. “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.”