FDA Approves Benralizumab as Self-Administered Injectable for Treatment of Moderate-to-Severe Asthma

By Jeff Craven /alert Contributor
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The FDA has approved benralizumab (Fasenra) as a self-administered, preloaded injectable medication for patients with moderate-to-severe eosinophilic asthma, according to a recent announcement from Astrazeneca.

Fasenra is a monoclonal antibody that binds directly to the interleukin-5 (IL-5) receptor alpha on eosinophil and rapidly depletes eosinophils by attracting natural killer cells to induct apoptosis. Astrazeneca said Fasenra will be available as a fixed, single-use subcutaneous injection (30 mg) or in pen form with a thin 29-gauge needle to be administered every 4 weeks for the first three doses and once every 8 weeks after.


Syringe. Source: Getty

“Fasenra is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D at Astrazeneca, stated in a press release. “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.”

The FDA approved the benralizumab auto-injector (Fasenra Pen) based on results from two trials: the phase III GRECO trial and the phase I AMES trial. In the GRECO trial, 120 adult patients with severe, uncontrolled asthma received a fixed 30 mg dose of Fasenra subcutaneously every 4 weeks at home or in a clinic. At 12 weeks and 16 weeks, 97% of patients successfully administered the treatment on their own or with the help of caregivers, and 96% of the devices returned by patients were deemed functional at 12 weeks and 16 weeks. The most common adverse events for patients were viral upper respiratory tract infection, asthma, upper respiratory tract infection, and headache.

In the multicenter, randomized, open-label, parallel-group AMES trial, researchers compared the pharmacokinetic exposure of Fasenra in healthy individuals after they received a subcutaneous dose of 30 mg with either a pre-filled syringe or a pre-filled Fasenra Pen. They found both interventions caused rapid eosinophil depletion, and a similar safety profile in both groups. The most common adverse events in the AMES trial were nasopharyngitis, headache, and oropharyngeal pain.

 

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