Novartis receives FDA approval for self-injection of Xolair

The Food and Drug Administration has given its stamp of approval for Xolai (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved U.S. indications.

Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E, or IgE for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticarial, or 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, Novartis president. "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."

"Expanding treatment options for personalized care and self-management is always welcome news for the patient community," said Kenneth Mendez, CEO and president of, the 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."

Novartis and Genentech, a member of the Roche Group, work together to develop and co-promote Xolair.

Xolair is indicated for moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids; nasal polyps in people 18 years of age and older when medicines to treat nasal polyps called nasal corticosteroids have not worked well enough; chronic idiopathic urticaria (CIU, chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment.