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FDA approves single-use auto-injector form of IL-5 inhibitor Fasenra

Published on 04/10/19 at 09:19am

AstraZeneca is celebrating as the FDA announced the approval of its IL-5 inhibitor Fasenra  (benralizumab) in a pre-filled, single-use auto-injector form, known as the Fasenra Pen.

The decision was based on Phase 1 and 3 data from two separate trials, and follows the product’s approval in the EU. Fasenra is currently approved in the US, EU, and Japan as an add-on treatment for eosinophilic asthma.

Data from these trials indicated that 97% of administrations in the 120 at-home patients, conducted by either the patients themselves or their caregiver, were successful at weeks 12 and 16. Furthermore, it was demonstrated that 96% of the auto-injectors that were returned were still functional at weeks 12 and 16.

“Fasenra is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period,” explained Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca. “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.”

Matt Fellows

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