Alarmed by side ef­fect, FDA slaps clin­i­cal hold on Sarep­ta's next-gen Duchenne drug

Sarep­ta Ther­a­peu­tics’ next-gen Duchenne mus­cu­lar dy­s­tro­phy drug has been hit with a clin­i­cal hold af­ter in­ves­ti­ga­tors flagged a se­ri­ous case of low mag­ne­sium lev­els in one pa­tient’s blood.

Screen­ing and dos­ing will be halt­ed in what is known as Part B of the Phase II MO­MEN­TUM study, which has en­rolled about half of the planned pa­tients. Sarep­ta said it will be sub­mit­ting in­for­ma­tion on all cas­es of the con­di­tion, known as hy­po­mag­ne­semia, per the FDA’s re­quest and propos­ing some changes to the risk mit­i­ga­tion and safe­ty mon­i­tor­ing plan.

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