FDA panel backs approval of Novo's semaglutide

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 with 1 abstention that safety and efficacy data support approval of subcutaneous semaglutide (NN9535) from Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO). The long-acting glucagon-like peptide-1 (GLP-1) analog is under review as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes.

In briefing documents released ahead of the meeting, FDA reviewers acknowledged that the candidate poses a risk of diabetic retinopathy, but noted that ophthalmology experts believe the program "does not raise any ophthalmic concerns.”...