Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will de­cide on Astel­las’ menopausal symp­tom drug by Feb. 22 of next year, as the Japan­ese phar­ma dis­closed it had paid about $97 mil­lion to get a pri­or­i­ty re­view vouch­er to speed up the re­view.

Astel­las said the agency has ac­cept­ed the phar­ma’s ap­pli­ca­tion for fe­zo­line­tant for the treat­ment of mod­er­ate to se­vere va­so­mo­tor symp­toms (VMS) as­so­ci­at­ed with menopause. VMS in­cludes hot flash­es and/or night sweats. The com­pa­ny said as many as 80% of women in the US ex­pe­ri­ence those symp­toms dur­ing or af­ter the menopausal tran­si­tion.

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