{"id":50931,"date":"2019-09-21T08:48:20","date_gmt":"2019-09-21T12:48:20","guid":{"rendered":"https:\/\/asweetlife.org\/?p=50931"},"modified":"2019-09-21T08:48:20","modified_gmt":"2019-09-21T12:48:20","slug":"fda-approves-first-glp-1-pill-novo-nordisks-rybelsus","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=50931","title":{"rendered":"FDA Approves First GLP-1 Pill, Novo Nordisk\u2019s Rybelsus"},"content":{"rendered":"

TheU.S. FDA has approved Rybelsus\u00a0<\/sup>(semaglutide), the first and only glucagon-like peptide-1 (GLP-1) analog in a pill.<\/p>\n

\u201cGLP-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,\u201d said Vanita R. Aroda, MD, Director of Diabetes Clinical Research, Brigham and Women’s Hospital, Boston, MA and a PIONEER clinical trial investigator. \u201cThe 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.\u201d<\/p>\n

The approval of Rybelsus\u00a0<\/sup>is based on results from 10 PIONEER clinical trials, which enrolled 9,543 participants and included head-to-head studies of Rybelsus\u00a0vs. sitagliptin, empagliflozin and liraglutide 1.8 mg.\u00a0In the trials, Rybelsus\u00a0reduced 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 trials.<\/p>\n

\u201cPeople living with type 2 diabetes deserve more innovation, research and support to help them achieve their individual A1C goals,\u201d said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. \u201cWith 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.\u201d<\/p>\n

Rybelsus\u00a0is approved for once-daily use in two therapeutic doses, 7 mg and 14 mg, and will be\u00a0available in the U.S. beginning in Q4 2019. Initial supply of Rybelsus\u00a0will come from manufacturing facilities in Denmark; however, future supply for Rybelsus\u00a0will come from manufacturing facilities in the U.S. In 2015, Novo Nordisk made a strategic investment to build a new manufacturing\u00a0facility in Clayton, NC to prepare for the future demand for\u00a0Rybelsus. Additionally, earlier this year Novo Nordisk acquired a tableting and packaging facility in Durham, NC to meet anticipated supply needs for\u00a0Rybelsus.<\/p>\n

Novo Nordisk is working with health insurance providers with a goal of ensuring broad insurance coverage and patient access to the product. A savings card program 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.<\/p>\n

The U.S. FDA is still reviewing Novo Nordisk\u2019s new drug application (NDA) for Rybelsus\u00a0seeking an additional indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease (CVD). A decision is expected in Q1 2020.<\/p>\n

Rybelsus\u00a0is currently under review by several regulatory agencies around the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.<\/p>\n

Rybelsus\u00a0is not for use in people with type 1 diabetes and people with diabetic ketoacidosis<\/p>\n","protected":false},"excerpt":{"rendered":"

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