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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