FDA

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.

Bottom line:

Both doses of semaglutide (0.5 mg and 1.0 mg) demonstrated superiority to placebo for the primary endpoint in the monotherapy Trial 3623 as well as Trial 3627 with basal insulin background therapy. Both doses of semaglutide also demonstrated superiority to active comparators sitagliptin and insulin glargine for the primary endpoint. Semaglutide 1.0 mg demonstrated superiority to exenatide ER. Results from the subgroup analyses for the HbA1c endpoint suggest the treatment effect of semaglutide is consistent across different subgroups.

The insiders also offered their stamp of approval on the drug’s ability to knock off pounds — a key attribute that should help this drug live up to its blockbuster projections. And the review noted no unexpected surprises in the extensive safety data collected on this drug, with no evidence of an elevated cardio risk.

The FDA did ask for some more data, but not necessarily before an approval. Semaglutide has been linked to a higher risk of diabetic retinopathy, with incidents of blindness. According to the review:

Additional data are needed to assess whether a slower reduction in HbA1c among subjects with a history of retinopathy treated with semaglutide would result in a lower risk of retinopathy, or to assess the risk of retinopathy beyond 2 years of exposure.

This will be a major point of discussion.

About a year ago Novo Nordisk offered data to prove their drug could reduce the risk of major cardio events by 26% among high-risk patients, beefing up a drug profile that has already impressed a range of analysts interested in the diabetes field.

And just two months ago Novo also outlined how its drug handily whipped Eli Lilly’s Trulicity, with a significantly higher rate of patients hitting their treatment goals. That study also came through without the earlier signs of diabetic retinopathy that had alarmed observers earlier.

Add it all up and, barring any unexpected revelations or a strongly negative take on the retinopathy issue, Novo Nordisk could well be on its way to gaining an OK here — with a followup shot on obesity that could make it a trendsetter in one of the toughest indications on the market.


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