AstraZeneca and its global biologics development arm MedImmune recently announced that the U.S. FDA has approved the listing of Fasenra (benralizumab) for the additional maintenance of severe asthma in patients with eosinophilic phenotype 12 years of age and older.
Asthma affects 315 million people worldwide and up to 10% of asthmatics have severe asthma. These patients are unable to control their asthma even with high doses of standard medications. Severe uncontrolled asthma is debilitating and may be fatal, leaving patients with exacerbated disease, severely limited lung function and quality of life. Severe uncontrolled asthma has a higher risk of mortality than severe asthma and may also result in patients dependent on oral corticosteroids (OCS), whereas systemic exposure to steroids can cause serious short-term and long-term side effects including weight gain, diabetes, bone loss Osteoporosis, glaucoma, anxiety, depression, cardiovascular disease and immunosuppression. In addition, these patients also bear a huge financial burden. They urgently need new therapies to help alleviate the disease and improve the quality of life.
Significantly reduced seizure frequency and hormone use
The advent of Fasenra is expected to bring a therapeutic dawn to this patient base. It is a monoclonal antibody that recruit natural killer cells to induce almost complete depletion of eosinophils directly and quickly. Eosinophils are bio-effector cells in about 50% of asthmatic patients, causing frequent episodes of disease, impaired pulmonary function, and asthma symptoms. A previous Phase 2 trial has shown that Fasenra's consumption of circulating eosinophils is rapid and can work within 24 hours. In key Phase 3 clinical trials SIROCCO and CALIMA, Fasenra significantly reduced the episode of severe uncontrolled eosinophilic asthma, improving lung function and asthma symptoms. Fasenra will be injected subcutaneously through a prefilled syringe, with the first 3 doses being given every 4 weeks and every 8 weeks thereafter.
The FDA approval of Fasenra is based on the results of the WINDWARD project - including the key Phase 3 exacerbations SIROCCO and CALIMA, and the Phase 3 OCS trial ZONDA. The results showed that patients receiving 8-week benralizumab dosing regimen:
The annual asthma attack rate (AAER) decreased by nearly 51% compared with placebo
Significant improvement in lung function, forced expiratory volume in one second (FEV1) 159 ml more than in the placebo group and differences after 4 weeks of administration
Daily OCS use decreased on average by 75% and 52% of eligible patients discontinued OCS
The overall adverse event situation is similar to placebo
"This is an important day for patients with severe eosinophilia," said Dr. Eugene Bleecker, key phase 3 SIROCCO study lead author, PhD, professor and co-director of genomics and precision medicine at the University of Arizona Department of Health Sciences. Lack of treatment options, many patients need to rely on oral steroids to control the symptoms.Fasenra has a strong clinical manifestations, including the ability to improve lung function after the first dose, to reduce or even stop the potential of oral steroids, and 8 weeks to Fasenra also treats different patient phenotypes, helping doctors to confidently choose the right patient in clinical practice. "
Dr. Pascal Soriot, CEO of AstraZeneca, said: "We are pleased to be able to offer Fasenra as a new precision biologic to help improve the lives of patients with severe asthma due to eosinophilic inflammation, our respiratory biologics product The initial approval of the portfolio is also the latest result of a series of key milestones for our company's pipeline-driven transformation. "
We expect this new drug will bring hope of treatment to patients with severe asthma.