The U.S. Food and Drug Administration has approved Fasenra (benralizumab) for the treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype, AstraZeneca said Wednesday.
Asthma affects 24 million individuals in the U.S., and up to 10 percent of patients have severe asthma, which may be uncontrolled despite high doses of standard-of-care asthma controller medicines.
Severe, uncontrolled asthma is potentially fatal with patients experiencing various severity and significant limitations on lung function and quality of life. It can lead to serious short- and long-term adverse effects, including weight gain, diabetes, osteoporosis, glaucoma, anxiety, depression, cardiovascular disease, and immunosuppression.
The physical and economic burden of severe, uncontrolled asthma accounts 50 percent of asthma-related costs for patients.
Fasenra is a monoclonal antibody that recruits natural killer cells to induce direct, rapid and near-complete depletion of eosinophils, a type of white blood cell that is a regular part of the body’s immune system.
The drug is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours, as observed in a phase 2 study, the company said.
Fasenra binds directly to the IL-5α receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis (programmed cell death). In the phase 2 trial, Fasenra demonstrated the significant reduction in exacerbations and improved lung function and asthma symptoms in severe, uncontrolled eosinophilic asthma patients.
“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,” said Pascal Soriot, chief executive officer of AstraZeneca. “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.”
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