FDA Approves Genentech’s Xolair for Self-Injection Across Indications

Roche subsidiary Genentech has secured a supplemental approval from the FDA for its Xolair (omalizumab) prefilled syringe for self-injection.

The agency approved the company’s supplemental Biologics License Application (sBLA), allowing the self-injected product to be used for treating moderate-to-severe persistent allergic asthma, chronic idiopathic urticaria and nasal polyps. The drug works by targeting and blocking the antibody immunoglobulin E.

Patients must have “no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity,” Genentech said.

Xolair, which Genentech sells in the U.S. with Novartis, was first FDA-approved in 2003 as an injectable medicine.