FDA questions hypoglycemia risk for Novo Nordisk’s once-weekly insulin ahead of adcomm

The FDA is rais­ing con­cerns about in­creased rates of hy­po­glycemia fol­low­ing treat­ment with No­vo Nordisk’s ex­per­i­men­tal once-week­ly basal in­sulin ahead of an ad­vi­so­ry com­mit­tee meet­ing on Fri­day.

In brief­ing doc­u­ments pub­lished Wednes­day, reg­u­la­tors not­ed high­er rates of hy­po­glycemia among pa­tients who took No­vo’s once-week­ly in­sulin icodec com­pared to those who took dai­ly in­sulin degludec, al­so known as No­vo’s Tre­si­ba.

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