The long-acting glucagon-like peptide-1 (GLP-1) receptor agonist was approved in 0.5-mg and 1.0-mg doses, to be administered once weekly via a dedicated prefilled pen device. The decision follows an October 2017 advisory panel endorsement.
Semaglutide is now the seventh GLP-1 receptor agonist on the US market and the third dosed once weekly. However, data suggest it might be more effective than some of its competitors.
The company's eight phase 3a trials involved over 8000 adults with type 2 diabetes, including individuals at high cardiovascular risk and those with renal disease. One of the studies, SUSTAIN-6, was a 2-year FDA-mandated cardiovascular-outcomes trial involving 3297 patients.
In the five SUSTAIN efficacy trials, semaglutide reduced hemoglobin A1c by 1.5 to 1.8 percentage points, significantly more than did active comparators — including the competing long-acting GLP-1 agonist exenatide extended release (Bydureon, AstraZeneca) in one of the trials.
Semaglutide was also associated with a 4.5- to 6.4-kg weight loss. The most common side effect was mild to moderate nausea, which diminished over time.
After approval, Novo Nordisk is required to conduct a pediatric trial in adolescents younger than 18 years of age and to add semaglutide to a 15-year medullary thyroid carcinoma registry that includes all of the long-acting GLP-1 products.
Semaglutide will be priced similarly to current weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce copays for eligible commercially insured patients, a Novo Nordisk spokesperson told Medscape Medical News.
Semaglutide is also under review by several other regulatory agencies, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
FDA Approves Semaglutide for Type 2 Diabetes - Medscape - Dec 05, 2017.