Rybelsus gets the go-ahead
FDA approves Rybelsus, the first GLP-1 analog treatment available in pill format
PLAINSBORO, N.J.—Novo Nordisk has announced the U.S. Food and Drug Administration (FDA) approved of Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes. Rybelsus is the first and only glucagon-like peptide-1 (GLP-1) analog in pill format. It is a new option for adults with type 2 diabetes who are not achieving their A1C goal with current anti-diabetic treatment.
“GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized in part because they have, until now, only been available as an injectable treatment,” said Vanita R. Aroda, M.D., director of Diabetes Clinical Research at Brigham and Women’s Hospital in Boston, and a PIONEER clinical trial investigator. “The availability of an oral GLP-1 receptor agonist represents a significant development and primary care providers, specialists and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals.”
The approval of Rybelsus is based on results from 10 PIONEER clinical trials, which enrolled 9,543 participants and included head-to-head studies of Rybelsus vs. sitagliptin, empagliflozin and liraglutide 1.8 mg. In the trials, Rybelsus reduced A1C, and as a secondary endpoint showed reductions in body weight. The most common adverse reactions in the PIONEER trials, reported in ≥5% of patients, were nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation. The types and frequency of the adverse reactions were similar across all trials.
“People living with type 2 diabetes deserve more innovation, research and support to help them achieve their individual A1C goals. With Rybelsus, we have the opportunity to expand use of effective GLP-1 receptor agonist therapy by providing adults with type 2 diabetes an oral medication which was previously only available as an injection to help with managing their blood sugar,” stated Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk.
Rybelsus is approved for once-daily use in two therapeutic doses, 7 mg and 14 mg. It will be available in the U.S. beginning in the fourth quarter of 2019. Initial supply of Rybelsus will come from manufacturing facilities in Denmark; future supply for Rybelsus is expected to come from manufacturing facilities in the U.S. In 2015, Novo Nordisk began building a new manufacturing facility in Clayton, NC to prepare for the future demand for Rybelsus. Earlier this year Novo Nordisk also acquired a tableting and packaging facility in Durham, NC to meet anticipated supply needs for Rybelsus.
Rybelsus is currently under review by several regulatory agencies around the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency. The FDA is still reviewing Novo Nordisk’s new drug application (NDA) for Rybelsus seeking an additional 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. A decision is expected in the first quarter of 2020.