AstraZeneca has received approvals in Japan for treatments of asthma and ovarian cancer.
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the Japanese Ministry of Health, Labour and Welfare had 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.
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.
And AstraZeneca and Merck & Co announced that the Japanese Ministry of Health, Labour and Welfare had approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy.
Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor to be approved in Japan.