Novartis receives FDA approval of Xolair

Novartis today announced that the US Food and Drug Administration (FDA) approved the supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved US 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 FDA approval represents an important milestone for Xolair and highlights our continued commitment to innovation for patients since its first approval in 2003,” said Victor Bultó, President, Novartis Pharmaceuticals Corporation. “With the new offering of self-injection for Xolair, healthcare providers now have an additional administration option for appropriate patients, which is particularly timely given 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 may determine whether self-injection with Xolair pre-filled syringe by the patient or caregiver is appropriate. The healthcare provider must train the patient or caregiver on the correct subcutaneous injection technique, how to recognize the signs and symptoms of anaphylaxis and how to treat anaphylaxis appropriately, before the first self-injection outside a healthcare setting.

“Expanding treatment options for personalized care and self-management is always welcome news for the patient community,” said Kenneth Mendez, CEO and President, Asthma and Allergy Foundation of America. “The possibility of administering FDA-approved treatment outside of the healthcare provider’s office, but still guided by that healthcare provider, may reduce barriers to care for patients and their caregivers.”

Approximately 460,000 patients have been treated in the US with Xolair since its initial approval in 2003.2 The use of Xolair across allergic asthma, CIU and nasal polyps is based on a well-established efficacy and safety profile which is supported by a robust clinical development program, including 10 Phase III studies.

In the US, Novartis Pharmaceuticals Corporation and Genentech, a member of the Roche Group, work together to develop and co-promote Xolair. PR News Wire