AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
Pascal Soriot, Chief Executive Officer of AstraZeneca, said: “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. 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.”
The FDA approval is based on results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III oral corticosteroid (OCS)-sparing trial, ZONDA. Results for the 8-week benralizumab dosing regimen from these trials showed:
Up to 51% reduction in the annual asthma exacerbation rate (AAER) versus placebo
Significant improvement in lung function as measured by forced expiratory volume in one second (FEV1) of up to 159mL versus placebo. Differences were seen as early as 4 weeks after the first dose, providing an early indication of effectiveness
75% median reduction in daily OCS use and discontinuation of OCS use in 52% of eligible patients
An overall adverse event profile similar to that of placebo
Eugene Bleecker, MD, Professor and Co-Director, Genetics, Genomics and Precision Medicine, University of Arizona Health Sciences, and lead investigator of the pivotal Phase III SIROCCO study, said: “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. 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. Fasenraalso treats a distinct patient phenotype, helping physicians select the right patient in clinical practice with more confidence.”
Fasenra is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours. Eosinophils are a type of white blood cell that are a normal part of the body's immune system. Elevated levels of eosinophils, seen in about half of severe asthma patients, impact airway inflammation and airway hyper-responsiveness, resulting in increased asthma severity and symptoms, decreased lung function and increased risk of exacerbations.
Fasenra binds directly to the IL-5α receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis (programmed cell death). Fasenra will be available as a once every 8-week fixed-dose subcutaneous injection via a prefilled syringe.
On 10 November, 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorisation of benralizumab. Benralizumab is also under regulatory review in Japan and several other countries.