08:48 AM EDT, 03/27/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Wednesday that the Japanese Ministry of Health, Labor, and Welfare approved two of its products for use in the country.

The company said the Japanese regulator approved the combination therapy of Truqap, or capivasertib, and Faslodex, or fulvestrant, to treat adults with unresectable or recurrent hormone receptor-positive, HER2-negative breast cancer with specific biomarker alterations following progression after endocrine therapy.

Additionally, AstraZeneca ( AZN ) and Sanofi's ( SNY ) monoclonal antibody Beyfortus, or nirsevimab, was approved in Japan as a prophylaxis to prevent lower respiratory tract disease caused by respiratory syncytial virus in neonates, infants, and children entering their first RSV season, as well as those at risk of serious RSV infection entering their first or second RSV season, AstraZeneca ( AZN ) said.

The approval of Beyfortus, AstraZeneca ( AZN ) said, is based on the treatment's efficacy demonstrated in three pivotal late-stage clinical trials, while the approval of Truqap plus Faslodex was based on a phase 3 trial showing a 50% reduction in the risk of disease progression or death.

AstraZeneca ( AZN ) said Truqap was discovered through a partnership with Astex Therapeutics, which now stands to receive a milestone payment from AstraZeneca ( AZN ) with the first commercial sale of the drug in Japan, along with royalties from future sales.

Shares of AstraZeneca ( AZN ) were up 1.3% in recent Wednesday premarket activity, while Sanofi ( SNY ) shares retreated 0.6%.

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