The US FDA has accepted the a supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair (omalizumab) across all approved US indications, including asthma, according to Genetech.
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, Genetech said.
In the US, 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).
Xolair for subcutaneous use is an injectable prescription medicine approved by the FDA to treat:
- Moderate to severe persistent asthma in patients six years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if a patient has allergies to year-round allergens.
- Chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment.
If the sBLA is approved, once Xolair 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.
“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 Xolair self-administration available as quickly as possible to provide patients with greater flexibility to manage their treatment needs.”