FDA gives No­vo Nordisk top grades for its di­a­betes drug semaglu­tide, but retinopa­thy re­mains key

In as­sess­ing No­vo Nordisk’s GLP-1 di­a­betes drug semaglu­tide for an up­com­ing pan­el re­view, in­sid­ers at the FDA nod­ded over the way re­searchers han­dled a few se­lect chal­lenges, of­fer­ing an ‘A’ on ef­fi­ca­cy and (most­ly) safe­ty as the ex­perts prepped for their meet­ing on Wednes­day.

There will be close at­ten­tion to ev­i­dence of di­a­bet­ic retinopa­thy, as the FDA care­ful­ly point­ed the pan­el to da­ta sug­gest­ing that a rapid drop in HbA1c could cause safe­ty prob­lems for pa­tients. But the over­all pos­i­tive tenor in the re­view clear­ly im­pressed in­vestors, who sent the stock $NVO up 3% in pre-mar­ket trad­ing this morn­ing.

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