FDA de­ci­sion on Sarep­ta’s Duchenne gene ther­a­py could come ear­li­er than ex­pect­ed

Sarep­ta Ther­a­peu­tics’ chief sci­en­tist sug­gest­ed that the FDA was ahead of sched­ule in re­view­ing the com­pa­ny’s ap­pli­ca­tion to ex­pand the la­bel of its Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py Ele­v­idys.

“We’ve been in­formed by the agency that they will be send­ing us the draft la­bels soon­er than they had pre­vi­ous­ly in­di­cat­ed,” Sarep­ta’s top sci­en­tist Louise Rodi­no-Kla­pac said dur­ing an earn­ings call Wednes­day af­ter­noon.

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