FDA approves Xolair prefilled syringes for self injection

April 14, 2021

Roche announced that the U.S. Food and Drug Administration (FDA) has approved the use of prefilled syringes of Xolair (omalizumab) for self-injection across all approved indications.

Roche said 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.

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 prefilled syringe by the patient or a 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 U.S. with Xolair since its initial approval in 2003.

In the U.S., Genentech, a member of the Roche group, and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair, Roche said.

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