Astel­las' menopause drug hit by FDA de­lay af­ter spend­ing $97M on a pri­or­i­ty re­view vouch­er

In Au­gust, Astel­las an­nounced that an ap­pli­ca­tion for its menopausal symp­tom drug fe­zo­line­tant had been ac­cept­ed, and it used a pri­or­i­ty re­view vouch­er — to which it as­cribed a $97 mil­lion val­ue — to speed up the process by four months.

The orig­i­nal de­ci­sion dead­line was Feb. 22, but to­day the Japan­ese phar­ma an­nounced that the FDA is ex­tend­ing the orig­i­nal PDU­FA date by three months to May 22.

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