Novo's week­ly in­sulin se­cures CHMP thumbs-up as FDA de­ci­sion looms

No­vo Nordisk is an­oth­er step clos­er to launch­ing its once-week­ly in­sulin icodec now that the Eu­ro­pean Med­i­cines Agency’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) has rec­om­mend­ed it for mar­ket­ing au­tho­riza­tion.

No­vo said Thurs­day that it ex­pects to have full au­tho­riza­tion in the EU with­in about two months.

While No­vo’s pro­gres­sion of its once-week­ly in­sulin shot has been over­shad­owed by im­pres­sive weight loss da­ta from its oral amy­cretin and semaglu­tide’s mar­ket suc­cess, an ap­proval would make No­vo the first to of­fer basal in­sulin on a week­ly in­stead of a dai­ly ba­sis. No­vo is al­so in­ves­ti­gat­ing icodec with its GLP-1 semaglu­tide.

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