FDA approves oral semaglutide, first oral GLP-1 receptor agonist for diabetes.

The FDA on Friday approved oral semaglutide, the first noninjectable GLP-1 receptor agonist for the treatment of type 2 diabetes, according to an agency press release.

The approval follows several large trials for oral semaglutide (Rybelsus, Novo Nordisk) that demonstrated the therapy was associated with superior HbA1c reductions vs. placebo (PIONEER 4), vs. the oral SGLT2 inhibitor empagliflozin (PIONEER 2; Jardiance, Boehringer Ingelheim) and vs. the oral DPP-IV inhibitor sitagliptin (PIONEER 3; Januvia, Merck). Oral semaglutide also provided significant weight loss at 52 weeks for participants with type 2 diabetes uncontrolled with metformin therapy.

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“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,” Lisa Yanoff, MD, acting director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Before this approval, patients did not have an oral GLP-1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections.”

In PIONEER 2, participants assigned oral semaglutide experienced a greater reduction in HbA1c vs. empagliflozin at 26 weeks (treatment policy mean reduction, –1.3%; trial product mean reduction, –0.9%; P < .0001), with similar results at 52 weeks, according to findings reported at the American Diabetes Association Scientific Sessions in June. In PIONEER 4, At 26 weeks, researchers observed similar reductions in HbA1c in the semaglutide group vs. the liraglutide group for noninferiority of semaglutide to liraglutide.

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In the placebo-controlled studies, 69% of patients assigned to 7 mg oral semaglutide and 77% of patients assigned to 14 mg oral semaglutide decreased their HbA1c to 7% or lower at 26 weeks, compared with 31% of patients assigned placebo, according to the FDA.
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In a press release from Novo Nordisk announcing the approval, Vanita R. Aroda, MD, director of diabetes clinical research at Brigham and Women's Hospital in Boston and a PIONEER clinical trial investigator, said GLP-1 receptor agonists are effective medications for people with type 2 diabetes that have been underutilized. “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,” Aroda said in the release.

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