No­vo Nordisk slammed with an RTF as the FDA rais­es CMC is­sues

No­vo Nordisk’s block­buster di­a­betes drug Ozem­pic (semaglu­tide) has al­ready made the Dan­ish drug­mak­er bil­lions of dol­lars, and the com­pa­ny is aim­ing to cap­i­tal­ize on that suc­cess by ex­pand­ing in­to high­er dos­es and oth­er in­di­ca­tions like obe­si­ty and NASH. But late Mon­day the FDA told No­vo: “Not so fast.”

US reg­u­la­tors slammed No­vo with an RTF let­ter for a once-week­ly semaglu­tide in­jec­tion at the 2 mg dos­ing lev­el, dou­ble the cur­rent high­est-ap­proved dose of the drug, for type 2 di­a­betes. Ac­cord­ing to No­vo’s an­nounce­ment, the FDA want­ed to see more in­for­ma­tion re­gard­ing a pro­posed new man­u­fac­tur­ing site.

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