AstraZeneca hails US approval for respiratory auto-injector
Cambridge headquartered Big Biotech torchbearer AstraZeneca has crossed the respiratory Rubicon with FDA approval for a major breakthrough product to treat severe asthma.
The 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, the company’s executive VP, BioPharmaceuticals R & D, said: “Fasenra is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period.
“This 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.
The US approval of the Fasenra Pen provides healthcare professionals and patients the option for Fasenra to be administered outside of a clinical setting via auto-injector by a patient or caregiver after their healthcare professional decides it is appropriate. The Fasenra pre-filled syringe is available for administration by a healthcare professional.
The Fasenra Pen enables patients and caregivers to administer the medicine via a simple two-step process. The device includes a viewing window and audible clicks at the start and end of the injection to guide patients with successful administration.
Fasenra is a monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).3,4
It is AstraZeneca’s first respiratory biologic, now approved as an add-on maintenance treatment in severe eosinophilic asthma in the US, EU, Japan and other countries, with further regulatory reviews ongoing.