This decision, based on the STEP UP and STEP UP T2D clinical trials, paves the way for a more potent therapeutic option for patients dealing with obesity. Results indicated that the 7.2 mg dose achieved an average weight loss of 20.7% after 72 weeks in non-diabetic individuals, maintaining a safety profile similar to the currently approved 2.4 mg dose.
The positive opinion from the CHMP emphasizes that the benefits extend beyond weight reduction. Data showed that 84% of the weight lost was fat mass, preserving crucial muscle function. Furthermore, semaglutide has already demonstrated improvements in associated complications, such as reducing the risk of major cardiovascular events like heart attacks and strokes.
“"This new option could be available early next year, pending final approval from the EMA."
Pharmaceutical company Novo Nordisk, which also requested authorization for a single-dose administration device, anticipates the treatment will be available in early 2026 once the EMA grants final authorization, marking a significant step forward in obesity management.
