The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of semaglutide (Ozempic, Novo Nordisk) for the treatment of adults with type 2 diabetes.
The product, a once-weekly glucagon-like peptide-1 (GLP-1) analog, will be available as a 1.34-mg/mL injectable solution. It is indicated as an adjunct to diet and exercise when metformin fails to achieve glycemic targets, as monotherapy for those in whom metformin is not tolerated or contraindicated, and in combination with other glucose-lowering therapies.
The label will provide study results supporting combination use, as well as study data demonstrating weight loss and reductions in diabetic nephropathy with semaglutide relative to standard care.
The CHMP review of semaglutide was based on the SUSTAIN program. The program comprised eight phase 3a trials of more than 8000 adults with type 2 diabetes, including those at high cardiovascular risk and with renal disease. One of the studies, SUSTAIN-6, was a 2-year 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.
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.
The EMA is requiring Novo Nordisk to conduct postapproval safety studies, including a long-term diabetic retinopathy outcome study. The issue of a possible signal for retinopathy was discussed at length in a US Food and Drug (FDA) Advisory panel hearing in October 2017. The FDA subsequently approved semaglutide for the US market in early December.
And, as required for all long-acting GLP-1 products approved in the European Union, semaglutide data will be included in a medullary thyroid carcinoma registry.
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