AstraZeneca’s biologic Fasenra has picked up its first global approval in the US as a treatment for severe, eosinophilic asthma, a difficult to treat form of the condition.
Specifically, Fasenra (benralizumab) has been cleared as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
According to AZ, the approval is based on a Phase III programme which showed up to 51 percent reduction in asthma exacerbations, significant improvement in lung function of up to 159mL versus placebo, and a 75 percent reduction in daily oral steroid use.
Also of note, the drug an overall adverse event profile similar to that of placebo, the firm noted.
“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,” noted Eugene Bleecker, Professor and co-director, Genetics, Genomics and Precision Medicine, University of Arizona Health Sciences, and lead investigator of the pivotal Phase III SIROCCO trial.
“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,” he adding, also highlighting that it treats “a distinct patient phenotype, helping physicians select the right patient in clinical practice with more confidence.”
AZ says Fasenra is the only respiratory biologic that provides “direct, rapid and near-complete depletion of eosinophils within 24 hours.” It works by binding directly to the IL-5α receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis.
Benralizumab is in-licensed from BioWa, a wholly-owned subsidiary of Kyowa Hakko Kirin. Under the exclusive license agreement, the firms have exclusive development and commercialisation rights for benralizumab in Japan and certain countries in Asia. AZ has exclusive rights for the drug in all other countries including the US and Europe.