FDA OKs Novartis and Roche self-injectable

April 13, 2021

The U.S. Food and Drug Administration have approved the supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved indications. In the United States, Novartis and Roche's Genentech co-develop the med.

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

Before starting self-injection with the prefilled syringe, the patient must have no prior history of anaphylaxis and be observed by a healthcare provider for at least three injections with no allergic reactions. After therapy has been safely established in a healthcare setting, a healthcare provider may determine whether self-injection 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.

Approximately 460,000 patients have been treated in the US with Xolair since its initial approval in 2003.

Read the Novartis statement