Novo Nordisk NC Sites to Supply Newly Approved Diabetes Drug
The recently expanding Novo Nordisk drug-manufacturing operations in Durham and Clayton will provide U.S. supplies of the company’s new diabetes drug Rybelsus.
The U.S. Food and Drug Administration approved the oral GLP-1 receptor agonist. That’s shorthand for glucagon-like peptide-1, a hormone that can decrease blood sugar levels by stimulating the secretion of insulin in people with type 2 diabetes.
Clinical trials that enrolled more than 9,000 participants compared Rybelsus to other available treatments: sitagliptin, empagliflozin and liraglutide. The trials showed Rybelsus effective at reducing blood glucose in A1C tests, and also at reducing body weight.
Rybelsus is approved for once-daily use in seven and 14 milligram dosages, and will be available in the U.S. in 2019.
Novo Nordisk is working with health insurers to ensure broad coverage and patient access. The company said eligible commercially insured patients can expect to pay as little as $10 out of pocket using the available savings card program.
A new drug application for another indication for Rybelsus is still under FDA. That’s for reducing MACE, an acronym for major adverse cardiovascular events, in adults with cardiovascular disease and type 2 diabetes. MACE includes such events as heart attack, stroke, or cardiovascular death. That decision is expected in the first quarter of 2020.
The treatment is also under review internationally by regulators such as European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.