Veoza NDA accepted in China for menopausal hot flushes – Astellas Pharma

Astellas Pharma Inc. announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for Veoza (fezolinetant 45 mg) seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

VMS, commonly known as hot flashes and night sweats, are among the most common symptoms associated with menopause and can significantly affect women’s sleep, daily activities and overall quality of life. 55% of women aged 40-65 years across East Asia, including Mainland China, have experienced moderate to severe VMS, underscoring the significant burden of menopausal symptoms and the continued need for effective treatment options.

The NDA submission is supported by data from the global Phase 3 BRIGHT SKY program, a new bridging study conducted in China and the previously completed clinical studies in China. Across all programmes, fezolinetant was generally well tolerated, with the most commonly reported adverse events including headache, abdominal pain, diarrhoea, insomnia and back pain.

Fezolinetant is a non-hormonal, selective neurokinin 3 (NK3) receptor antagonist specifically designed to block neurokinin B binding on kisspeptin/neurokinin/dynorphin neurons, which are involved in regulating the brain’s temperature control center. By targeting this pathway, fezolinetant helps reduce the frequency and severity of moderate to severe VMS associated with menopause. Fezolinetant is currently approved in 50 countries worldwide.

Astellas remains committed to advancing women’s health and expanding access to evidence-based treatment options for moderate to severe VMS associated with menopause.

Astellas has already factored the impact of this matter into its financial forecast for the current fiscal year ending March 31, 2027.