AstraZeneca asthma drug wins US regulatory approval for self-administration

AstraZeneca said on Friday that the US Food and Drug Administration has approved the self-administration of its Fasenra (benralizumab) for patients with severe eosinophilic asthma.

The treatment, which is applied using an auto-injector, has already been approved for self-administration in the European Union after the drug's safety and tolerability profile was supported by data from its phase III GRECO trial and the phase I AMES trial.

The pharmaceuticals company also said Fasenra has won approval for use as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and several other countries, while further regulatory reviews are ongoing.

Mene Pangalos, executive vice president of biopharmaceuticals research and development, 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."