ALPMY - Astellas' fezolinetant to treat menopause symptoms gets EMA review
- The European Medicines Agency (EMA) accepted to review Astellas Pharma's ( OTCPK:ALPMF ) ( OTCPK:ALPMY ) application seeking approval of oral drug fezolinetant to treat moderate to severe vasomotor symptoms (VMS) associated with menopause.
- VMS, commonly called hot flashes or flushes and night sweats, are common symptoms of menopause.
- The marketing authorization application (MAA) is backed by data from a program called BRIGHT SKY which included three phase 3 trials — SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4, the company said in a Sept. 29 press release.
- Astellas added that if approved by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause.
- The drug is also under review in the U.S .
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Astellas' fezolinetant to treat menopause symptoms gets EMA review