FDA to Review Omalizumab Prefilled Syringe for Self-Administration

The FDA is expected to make a decision by the first quarter of 2021.

The Food and Drug Administration (FDA) has accepted for filing the supplemental Biologics License Application (sBLA) for a new self-administration option for omalizumab (Genentech and Novartis) across all indications. 

Omalizumab, an anti-IgE antibody marketed under the brand name Xolair, is indicated for the treatment of moderate to severe persistent asthma in patients aged 6 years and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled by inhaled corticosteroids. Additionally, Xolair is approved to treat chronic idiopathic urticaria in symptomatic patients 12 years of age and older despite H1-antihistamine treatment.

Xolair is supplied in a prefilled syringe and as a lyophilized powder in a vial for reconstitution. If the sBLA is approved, the prefilled syringe would be available for subcutaneous (SC) self-administration outside of a healthcare setting to certain patients or caregivers. A healthcare professional would need to assess the appropriateness of self-administration and would also need to train the patient or caregiver on proper SC injection technique and recognition of the signs/symptoms of anaphylaxis. According to the Company, independent clinical studies have suggested the treatment could be self-administered with proper training and monitoring.

“If approved, self-administration of Xolair would offer a new, convenient and flexible treatment administration option for patients and healthcare providers, which builds on the proven legacy, safety profile and efficacy of Xolair over the last 17 years of real-world use.” said Victor Bultó, President, Novartis Pharmaceuticals Corporation.  

The FDA is expected to make a decision by the first quarter of 2021.

For more information visit Xolair.com.


Novartis announces FDA filing acceptance of Xolair® (omalizumab) prefilled syringe for self-administration across all indications. https://www.prnewswire.com/news-releases/novartis-announces-fda-filing-acceptance-of-xolair-omalizumab-prefilled-syringe-for-self-administration-across-all-indications-301111352.html. Accessed August 13, 2020. 

This article originally appeared on MPR