The US Food and Drug Administration has approved a self-administered version of benralizumab (Fasenra, AstraZeneca), which comes in a prefilled, single-use autoinjector (Fasenra Pen), the company has announced. Benralizumab is an antieosinophil humanized monoclonal antibody that selectively targets the interleukin-5 receptor expressed on the surface of eosinophils. Since 2017, it has been available in the United States in a fixed-dose prefilled syringe for subcutaneous administration in a physician's office as add-on maintenance treatment for adults and for children aged 12 years or older who have severe eosinophilic asthma. "The US approval of the Fasenra Pen provides healthcare professionals and patients the option for Fasenra to be administered outside of a clinical setting via auto-injector by a patient or caregiver after their healthcare professional decides it is appropriate," the company said in a news release. The Fasenra Pen features a viewing window and emits audible clicks at the start and end of the injection to guide patients during administration, the company said. The approval of the Fasenra Pen is supported by data from the GRECO trial and the AMES trial, which demonstrated safety and tolerability similar to that experienced with subcutaneous administration, "with no new or unexpected safety findings," the company said. Source
