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AstraZeneca treatments become ‘first and only’ to be approved in Japan

ALN

AstraZeneca PLC announced on Wednesday the approval of two of its treatments for use in Japan.

The Cambridge-based pharmaceutical company said Beyfortus, a long-acting monoclonal antibody, has been approved as a treatment to prevent lower respiratory tract disease in infants caused by respiratory syncytial virus. Beyfortus is being developed and commercialised by Astra in tandem with Paris-listed Sanofi SA.

Every year more than 100,000 cases in infants are reported in Japan, and AstraZeneca’s treatment is the ‘first and only’ of its kind to be approved in the country, the FTSE 100 listing said.

Furthermore, in recent trials, Truqap plus Faslodex treatment for breast cancer was found to reduce the risk of disease progression or death by 50% compared to Faslodex alone. Based on these results, it also became the first of its kind to be approved by the Japanese health ministry.

AstraZeneca’s Oncology Executive Vice President Dave Fredrickson said: ‘Breast cancer is the most common cancer among women in Japan, and innovative, new treatment options are urgently needed. Today’s approval of Truqap, a first-in-class AKT-inhibitor, represents a significant step forward for HR-positive breast cancer treatment and an important new option for approximately fifty per cent of patients who have tumours with these specific mutations or alterations.’

Regulatory applications for the combined treatment are currently under review in China and the European Union.

Shares in AstraZeneca were up 1.2% to 10,562.00 pence each in London on Wednesday morning.

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