AstraZeneca and its global biologics research and development arm, MedImmune, said on Friday that the Japanese Ministry of Health, Labour and Welfare has approved Fasenra (benralizumab) as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite treatment with high-dose inhaled corticosteroid and other asthma controllers.
The approval is based on the 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.1 Fasenra will be available as a fixed-dose subcutaneous injection in a prefilled syringe administered once every four weeks for the first three doses, and then once every eight weeks thereafter.1
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The approval of Fasenra, our first respiratory biologic medicine, in Japan closely follows the recent US and EU decisions and brings us another step closer to achieving our ambition of transforming care for severe asthma patients around the world.”
Fasenra binds directly to the IL-5α receptor on eosinophils, a type of white blood cell that are a normal part of the body’s immune system,2 and attracts natural killer cells to induce direct, rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).5,6,7 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.3,4
The Japanese approval follows US FDA approval in November 2017 and European Commission marketing authorisation in January 2018. Interactions with regulatory authorities in the rest of the world are on-going.
Image: The logo of AstraZeneca is seen on a medication package in a pharmacy in London, Britain, April 28, 2014. REUTERS/Stefan Wermuth/File Photo