FDA Approves Genentech sBLA Application for Xolair

Final approval decision for Xolair expected by mid-2021

Genentech, a member of the Roche Group, announced last week the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved U.S. indications. If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers. A decision on approval is anticipated by Q1 2021. In the U.S., Xolair is currently approved for administration by a healthcare provider in a healthcare setting, and is the only approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of patients with moderate to severe persistent allergic asthma and chronic idiopathic urticaria (CIU).

“Due to the COVID-19 pandemic, there is an urgent need to provide self-administration of Xolair to our patients, particularly those who are considered high-risk for severe illness,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “We look forward to working closely with the FDA to make self-administration available as quickly as possible to provide patients with greater flexibility to manage their treatment needs.”

If approved, once proper therapy has been established and closely observed by a healthcare provider, self-administration of Xolair prefilled syringe outside of a healthcare setting by a patient or caregiver may be deemed appropriate by the healthcare provider for select patients. In those instances, the patient or caregiver would be trained by a healthcare provider in the correct subcutaneous injection technique and recognition of the early signs and symptoms of anaphylaxis.

Approximately 460,000 patients have been treated in the U.S. with Xolair since its initial approval for allergic asthma in 2003. The use of Xolair in allergic asthma and CIU is supported by a robust clinical development program, including eight Phase III studies. Independent clinical studies involving patients with allergic asthma and CIU on Xolair treatment suggest that it may be self-administered with proper training and monitoring.

In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

About The Author

Each year more than 350,000 professionals advance their career with Elite Learning.