Benralizumab Approved by FDA as Self-Administered Auto-Injector for Asthma

The FDA has approved of the self-administration of Astrazeneca’s benralizumab (Fasenra) in a pre-filled, single-use auto-injector. The medicine gives U.S. healthcare providers and patients the option to administer the pen at home or in a doctor’s office and makes treatment more accessible to patients with severe eosinophilic asthma.

Benralizumab is a monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid depletion of eosinophils via programmed cell death.

The approval is supported by data from the Phase III GRECO trial and the Phase I AMES trial. Each trial tested the safety and tolerability of benralizumab and were consistent with the established profile of the medicine.

Known as the Fasenra pen, the auto-injector enables patients and caregivers to administer the medicine via a simple two-step process. It is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period.

Reference

Fasenra approved in the US for self-administration in a new pre-filled auto-injector, the Fasenra Pen [news release]. Astrazeneca Newsroom: October 4, 2019. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/fasenra-approved-in-the-us-for-self-administration-in-a-new-pre-filled-auto-injector-the-fasenra-pen-04102019.html. Accessed October 4, 2019.