Novo Nordisk’s once-weekly insulin will face FDA adcomm in May, following review extension

The FDA’s En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee will meet on May 24 to dis­cuss No­vo Nordisk’s ap­pli­ca­tion for a once-week­ly in­sulin.

The drug can­di­date, in­sulin icodec, is de­signed to re­duce pa­tients’ basal in­sulin in­jec­tions from sev­en a week to just one. But in De­cem­ber, the FDA told No­vo it would need an ex­tra three months to re­view the ap­pli­ca­tion be­cause of new da­ta that con­sti­tut­ed a “ma­jor amend­ment,” ac­cord­ing to the com­pa­ny.

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