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FDA approves Fasenra for eosinophilic asthma maintenance therapy
The FDA has approved Fasenra for additional maintenance treatment of severe eosinophilic asthma in patients 12 years and older, according to the manufacturer release.
The approval of Fasenra (benralizumab, AstraZeneca) stems from the results of a program of studies, which included phase 3 exacerbation trials and a phase 3 oral corticosteroid-sparing trial. The respiratory biologic, which diminishes eosinophils within 24 hours, has not been approved for the treatment of other eosinophilic conditions, or the relief of acute bronchospasms or status asthmaticus.
Fasenra is to be administered through subcutaneous injection every 4 weeks for the first three doses. After that, patients will need an injection of the biologic once every 8 weeks.
“We’re excited to offer Fasenra as a new precision biologic to help improve the lives of severe asthma patients whose disease is driven by eosinophilic inflammation,” Pascal Soriot, chief executive officer of AstraZeneca, said in a press release. “This is the first approval from our respiratory biologics portfolio and the latest in a series of significant milestones for our company as we deliver on our pipeline-driven transformation.”
According to the release, the results of the trials demonstrated many positive results, including a maximum reduction in annual exacerbation rate of 51% compared with placebo and notably improved lung function as assessed by an expiratory volume reaching 159 mL in 1 second.
Additionally, daily oral corticosteroid use decreased by a median of 75%, with 52% of patients ceasing use of the drug. Adverse events were comparable to placebo, with headache, pyrexia, pharyngitis and hypersensitivity reactions equaling at least 3% of the events.
“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long, with many relying on oral steroids to manage their symptoms,” Eugene R. Bleecker, MD, professor and co-director of genetics, genomics and precision medicine at University of Arizona Health Sciences, said in the release. “Fasenra has a strong clinical profile which includes the ability to show lung function improvement after the first dose, the potential to reduce — or even stop — oral steroid use and the convenience of 8-week dosing.”
Bleecker notes that the drug also can treat a different subgroup of patients, which may assist physicians in choosing the correct patient during clinical practice in a more confident manner.
Fasenra treats eosinophilic asthma by binding directly to IL-5alpha receptors on eosinophils. The drug then induces apoptosis to decrease eosinophils.
“Most people don’t appreciate the simple act of breathing until they can’t do it,” Karen Kempley, a patient with severe eosinophilic asthma, said in the release. “As someone with severe asthma, I know how devastating it is to not have control over your asthma and to live with the fear of not knowing when your next asthma attack might happen. When you can’t breathe, you can’t do the things you want or need to do — like go to work or be with your family — and that impacts every aspect of your life.”
Disclosure: Infectious Diseases in Children was unable to confirm relevant financial disclosures at the time of publication.