Fasenra approved in the US for self-administration in a new pre-filled auto-injector, the Fasenra Pen

AstraZeneca announced that the US Food and Drug Administration (FDA) has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen).

The approval is supported by data from the Phase III GRECO trial and the Phase I AMES trial. The safety and tolerability of Fasenra in these trials were consistent with the established profile of the medicine.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, 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.”

Fasenra self-administration and the Fasenra Pen are also approved in the European Union (EU). Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries.