Astellas files NDA for fezolinetant in Japan
Japanese drug major Astellas Pharma (TYO: 4503) has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labor and Welfare (MHLW) seeking approval of fezolinetant, a NK3 receptor antagonist, for the treatment of vasomotor symptoms (VMS, also known as hot flushes and sweating) associated with menopause.
The submission is supported by data from clinical studies conducted in Japan including two Phase III STARLIGHT studies in Japanese women, as well as data from the global clinical development program providing supportive context. If approved, fezolinetant would be the first nonhormonal treatment option in Japan to target the NK3 receptor pathway for women experiencing VMS associated with menopause.
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