The Food and Drug Administration (FDA) has approved Rybelsus (semaglutide; Novo Nordisk) to improve glycemic control in adults with type 2 diabetes (T2D) as an adjunct to diet and exercise.
Rybelsus is the first glucagon-like peptide (GLP-1) receptor agonist available in a tablet formulation that is approved for once daily use; it is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. The approval was based on results from ten PIONEER clinical trials that compared the safety and efficacy of Rybelsus with placebo, empagliflozin, sitagliptin, and liraglutide in patients with T2D (N=9543).
Findings from PIONEER 1 demonstrated Rybelsus 7mg and 14mg as monotherapy significantly reduced hemoglobin A1c to less than 7% after 26 weeks in 69% and 77% of patients, respectively, compared with 31% of patients administered placebo. Additionally, Rybelsus demonstrated a statistically significant reduction in HbA1c compared with empagliflozin and sitagliptin in the PIONEER 2 and PIONEER 3 trials, respectively, and non-inferior HbA1c reductions compared with liraglutide in the PIONEER 4 trial.
Regarding safety, the most common adverse reactions were nausea, abdominal pain, diarrhea, vomiting, decreased appetite, and constipation. Rybelsus carries warnings regarding pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury and hypersensitivity reactions.
According to the product labeling, Rybelsus is contraindicated in patients with personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. The labeling also includes a Boxed Warning advising healthcare professionals and patients about a potential risk of thyroid c-cell tumors observed in rodents; the human relevance of this finding has not been determined.
“Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition,” said Lisa Yanoff, MD, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Before this approval, patients did not have an oral GLP1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections.”
Rybelsus will be available beginning in the fourth quarter of 2019 as 3mg, 7mg, and 14mg strength tablets in 30-count bottles. It is currently under FDA review for an additional indication to reduce the risk of major adverse cardiovascular events (MACE), such as heart attack, stroke, or cardiovascular death in adults with T2D and established cardiovascular disease; a decision is expected in the first quarter of 2020.
For more information visit novonordisk-us.com.