FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

●  Xolair for self-injection offers healthcare providers and appropriate patients another administration option for more flexibility in managing their treatmentBasel, 13 April 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the company ’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. indications.1 Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.“Today ' s approval reflects our commitment to continued innovation with Xolair to address the critical needs of people living with allergic and inflammatory conditions, ” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.” Before starting self-injection with Xolair prefilled syringe, the patient must have no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity (allergic reactions). After Xolair therapy has been initiated and safely established in a healthcare setting, a healthcare provider ma...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news