The US Food and Drug Administration (FDA) has approved pre-filled auto-injector benralizumab (FASENRA) as a self-administered therapy for adults with asthma.
The indication makes the monoclonal antibody the first respiratory biologic available either at home or in a professional setting, with eight-week maintenance dosing.
The approval for the AstraZeneca therapy was supported on the findings from the phase 3 GRECO trial and phase 1 AMES trial, in which benralizumab showed usability and pharmacokinetic exposure benefits, respectively, in adults with asthma.
The GRECO trial included 121 patients in a multi-center, open-label assessment observing functionality, reliability and performance of single-use injection benralizumab in a home setting. In safety-related outcomes, just 1 patient reported a serious adverse event of a respiratory, thoracic, or mediastinal disorder through 28 weeks.
The benefit of an at-home injection therapy for adult asthma is amplified by the proven efficacy and safety profile of benralizumab, Reynold Panettieri, MD, vice chancellor for Translational Medicine and Science, and director of Rutgers Institute for Translational Medicine and Science, said in a statement.
“The importance of this approval is that my patients and I now have another option to personalize their treatment approach to help meet their needs and fit their lifestyle,” Panettieri said.
Today’s news means we can now offer FASENRA in an even more convenient way, giving US healthcare providers and patients the option of administering FASENRA at home or in a doctor’s office, and making treatment more accessible to patients with severe eosinophilic asthma,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D, said.