FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy re­view.

In Feb­ru­ary, No­var­tis an­nounced that an ap­pli­ca­tion for their much-tout­ed mul­ti­ple scle­ro­sis drug ofa­tu­mum­ab had been ac­cept­ed and, with the drug com­pa­ny cash­ing in on one of their pri­or­i­ty re­view vouch­ers, the agency was due for a de­ci­sion by June.

But with June less than 48 hours old, No­var­tis an­nounced the agency has ex­tend­ed their re­view, push­ing back the time­line for ap­proval or re­jec­tion to Sep­tem­ber. The Swiss phar­ma filed the ap­pli­ca­tion in De­cem­ber, mean­ing their new sched­ule will be near­ly in line with the stan­dard 10-month win­dow pe­ri­od had they not used the pri­or­i­ty vouch­er.

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