The FDA announced Friday the approval of Novo Nordisk’s Rybelsus (semaglutide) to improve control of blood glucose in adults with type 2 diabetes, along with diet and exercise, making it the first oral GLP-1 receptor agonist cleared in the US. Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, remarked “now patients will have a new option for treating type 2 diabetes without injections.”
According to Novo Nordisk, its filing was supported by data from 10 PIONEER clinical trials, which enrolled 9,543 participants and included head-to-head studies of Rybelsus versus Merck & Co.’s DPP-4 inhibitor Januvia (sitagliptin), Eli Lilly and Boehringer Ingelheim’s SGLT2 inhibitor Jardiance (empagliflozin), as well as the Danish drugmaker’s subcutaneous GLP-1 analogue Victoza (liraglutide).
Results from the trials demonstrated that Rybelsus reduced A1C and, as a secondary endpoint, showed reductions in body weight. The types and frequency of adverse reactions were similar across trials, Novo Nordisk noted. Vanita Aroda, a PIONEER clinical trial investigator, said “the availability of an oral GLP-1 receptor agonist represents a significant development,” as patients and primary care providers “may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals.”
Pareto Securities analyst Johan Unnerus suggested that “the oral administration is likely to make [Rybelsus] competitive for quite some time,” adding that the closest rivals will probably be Ozempic, a once-weekly injectable formulation of semaglutide that Novo Nordisk sells for nearly $800 per month, as well as Eli Lilly’s injectable GLP-1 receptor agonist Trulicity (dulaglutide), and possibly also Januvia. The analyst expects sales of Rybelsus to reach at least DKK 36.6 billion ($5.4 billion) in 2026.
The FDA said that Rybelsus includes a boxed warning to advise about the potential increased risk of thyroid c-cell tumours, while therapy is not recommended as the first choice of medicine for treating diabetes.
Novo Nordisk indicated that Rybelsus would be available in the US starting in the fourth quarter, and that it is working with health insurers to offer “broad” coverage and patient access to the product. The therapy will be “competitively priced within the GLP-1 category,” the company said, adding that “a savings card programme will be available at the time of launch for eligible commercially-insured patients to keep out of pocket costs down to as little as $10 a month.” The drugmaker also noted that while initial supplies of Rybelsus will come from manufacturing facilities in Denmark, future supply will be manufactured in the US.
Rybelsus is currently under review by regulatory agencies around the world, including in Europe and Japan. The company added that the FDA is also still assessing an application for Rybelsus seeking a further indication to reduce the risk of major adverse cardiovascular events, such as heart attack, stroke or cardiovascular death, in adults with type 2 diabetes and established cardiovascular disease, with a decision expected in the first quarter of 2020.