FDA Allows for Omalizumab Self-Injection Across All Indications


The approval of the sBLA means greater flexibility and reduced barriers in care during the pandemic.


The US Food and Drug Administration (FDA) has approved Genentech and Novartis’s supplemental Biologics License Application (BLA) for omalizumab (XOLAIR) allowing for self-injection with a pre-filled syringe across all indications.

Currently, the biologic is approved for the treatment of moderate to severe persistent allergic asthma in patients 6 years and older, chronic idiopathic urticaria in patients 12 years and older, and nasal polyps in those 18 years and older.

“Today's approval reflects our commitment to continued innovation with Xolair to address the critical needs of people living with allergic and inflammatory conditions,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development of Roche, in a statement.

“Appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the COVID-19 pandemic.”

Ensuring Proper Use

Following patient therapy initiation in a healthcare setting, the healthcare provider should determine whether self-injection or caregiver injection is appropriate. If so, the patient or caregiver must be trained on technique as well as how to recognize and treat the signs and symptoms of anaphylaxis.

Patients with a history of anaphylaxis should not perform self-injection of omalizumab. Furthermore, a healthcare provider is encouraged to closely observe all patients for at least 3 injections and ensure there is no hypersensitivity.

Omalizumab is subcutaneously administered as 1 or more injections every 2 or 4 weeks. People with asthma and nasal polyps are required to receive a blood test in order to determine appropriate dosage amount and frequency.

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