BRIEF—AstraZeneca wins approval for self-administered Fasenra

AstraZeneca has won US approval for a pre-filled, single-use auto-injector of Fasenra (benralizumab), dubbed the Fasenra Pen.

The approval is based on data from the Phase III GRECO trial and the Phase I AMES trial, which show the safety and tolerability of Fasenra were consistent with prior trials.

Executive VP of biopharma Mene Pangalos said: “Fasenra is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period.”

“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.”