The Japanese Ministry of Health, Labour and Welfare has approved Fasenra (benralizumab), from AstraZeneca (LON: AZN) and its global biologics research and development arm, MedImmune, the company disclosed on Friday.

The drug has been approved as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite receiving treatment with high-dose inhaled corticosteroid and other asthma controllers.

The decision was based on results from the WINDWARD programme, which included the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, as well as the Phase III oral corticosteroid (OCS)-sparing trial, ZONDA.

Fasenra will now be available to eligible patients in Japan as a fixed-dose subcutaneous injection in a pre-filled syringe administered once every four weeks for the initial three doses, and then once every eight weeks thereafter.

The approval in Japan follows approval from the US Food and Drug Administration (FDA) in November and marketing authorisation from the European Commission in January 2018. The company is continuing interactions with regulatory authorities in the rest of the world.