- Novo Nordisk (NVO -0.1%) has submitted two marketing applications to the FDA related to oral semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in pill form.
- The first application seeks approval as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes (T2D). It was made with a Priority Viewer Voucher which shortens the review clock to six months.
- The second application seeks a cardiovascular (CV) benefit claim, specifically, to reduce the risk of major adverse CV events (MACE) in adults with T2D with established CV disease. The company expects the standard 10-month review period for this filing.
- It has also submitted a supplemental marketing application for once-weekly Ozempic (semaglutide) injection (0.5 mg or 1.0 mg) seeking a CV benefit claim.