FDA ex­perts shrug off retinopa­thy con­cerns, of­fer (near) unan­i­mous thumbs up for No­vo Nordisk's semaglu­tide

An FDA pan­el of out­side ex­perts to­day vot­ed al­most unan­i­mous­ly to en­dorse No­vo Nordisk’s next big di­a­betes/obe­si­ty drug semaglu­tide, like­ly set­ting up a near-term ap­proval for one of this year’s top block­busters in the pipeline. There was one ab­sten­tion and ze­ro op­po­si­tion to the key ques­tion.

No­vo Nordisk is a ma­jor play­er in di­a­betes and pre­dictably ran a thor­ough late-stage ef­fort to nail down their drug’s abil­i­ty to low­er HbA1c — a crit­i­cal mea­sure for the con­trol of the dis­ease. In the process, though, they al­so care­ful­ly tracked in­ci­dents of di­a­bet­ic retinopa­thy — dam­age to the blood ves­sels in the eye, which can lead to blind­ness — spot­light­ing what would be­come a big is­sue for its sci­en­tists on Wednes­day.

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