AstraZeneca scores double approvals in Japan for asthma and ovarian cancer
AstraZeneca has unveiled a double dose of approvals awarded to its medicines in Japan: Fasenra (benralizumab) has been given authorisation as an add-on treatment for severe asthma sufferers, while Lynparza (olaparib) has been given the go-ahead as a maintenance therapy in patients with ovarian cancer who responded to chemotherapy, regardless of BRCA mutation status.
Just one week ago, Lynparza became the first poly ADP-ribose polymerase (PARP) inhibitor approved in the US for metastatic breast cancer, and with this latest approval the drug breaks the same ground in Japan as the first-such drug of its kind commercialised in the country. The decision was based on data which showed that the drug, when taken twice a day, could extend life without disease progression.
In Japan, ovarian cancer is the seventh most commonly diagnosed cancer, with more than 9,000 diagnosed each year, and the eighth most common cause of cancer deaths in women. The five-year survival rate is 58%.
“We are proud to bring this important first-in-class treatment to women with platinum-sensitive relapsed ovarian cancer in Japan who currently have very few treatment options,” said Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca. “The trials show that with Lynparza maintenance therapy, women with ovarian cancer can live longer without their disease worsening and Lynparza is well tolerated.”
Meanwhile, Fasenra is to be used to treat patients with bronchial asthma who continue to experience asthma exacerbations despite treatment with high-dose inhaled corticosteroid and other asthma controllers. The drug was approved in the US in November and Europe this month.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, commented on the approval: “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.”
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