Genentech, Novartis get FDA nod for self-injectable Xolair

Novartis headquarters
Certain limitations apply to the Xolair self-injection option. (Novartis)

The FDA has approved a self-injectable form of Genentech and Novartis’ Xolair. Introducing the new prefilled syringe product will free patients from the need to visit healthcare providers to get treated. 

Novartis, which co-promotes Xolair with Genentech in the U.S., won approval for a self-administered version of Xolair in the European Union in 2018. As the pandemic ramped up around one year ago, Marie-France Tschudin, president of Novartis Pharmaceuticals, told investors that home delivery of Xolair was “being accelerated across different markets.”

The FDA approval positions Novartis and Genentech to expand self-administration of Xolair to the U.S. Novartis said the option is “particularly timely given the COVID-19 pandemic” and Kenneth Mendez, CEO and president, Asthma and Allergy Foundation of America, welcomed the approval.

"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,” Mendez said in a statement.

Certain limitations apply to the self-injection option. Given the risk of anaphylaxis, self-injection is restricted to patients without a history of severe allergic reactions. Patients that are permitted to self-inject need to administer at least three doses under close observation of a healthcare provider with no allergic reactions.

The approval for self-injection covers all authorized indications for Xolair, including allergic asthma, and continues Novartis’ ongoing effort to expand and improve on the original version that won approval in 2003. Xolair originally came to market as a powder in a vial for reconstitution. The FDA approved a pre-filled syringe version in 2018.

While working to improve administration of Xolair, the U.S. syringe formulation patents for which expire in 2021 and 2025, Novartis has also been advancing a potential successor to the drug. Two phase 3 trials are comparing a next-generation monoclonal anti-immunoglobulin E antibody, ligelizumab, to Xolair in chronic spontaneous urticaria. Data are due this year.