FDA accepts application for self-administered Xolair use

The US Food and Drug Administration (FDA) has accepted Roche’s application for a new self-administration option for Xolair (omalizumab) across all approved US indications.

If it wins approval, Xolair profiled syringe would become available for either self-administration by certain patients or their caregivers.

In the US, Xolair is currently approved for administration by a healthcare provider in a healthcare setting. It is the only biologic approved which is designed to target and block immunoglobin E (IgE) for the treatment of moderate-to-severe persistent allergic asthma and chronic idiopathic urticaria (CIU).

Approximately 460,000 patients in the US have been treated with Xolair since its first approval for allergic asthma back in 2003. Its use in these settings is supported by a rigorous clinical development programme, including eight Phase III studies.

“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, 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,” he added.

If approved, patients will be able to self-administer Xolair once the therapy has been established and closely observed in a healthcare setting.