EU Approves Higher Wegovy Dose, Leading to 21% Weight Loss

The European Commission has approved a new 7.2 mg maintenance dose of the injectable medication Wegovy (semaglutide) for adults with obesity, which will be available in all European Union member states. This was reported by manilatimes.net.

The new dosage provides an additional therapeutic option for patients for whom the 2.4 mg treatment does not provide sufficient body weight reduction, leading to an average weight loss of 21% of body weight in clinical trials, compared to 14.9% of body weight with the previous maximum maintenance dose.

In the EU, the 7.2 mg dose can be administered as three 2.4 mg injections given simultaneously once a week. The company has already submitted an application for approval of a 7.2 mg single-dose pen, which could become available as early as this year.

The approval is based on the results of the STEP UP and STEP UP T2D clinical trials, which included people with obesity without diabetes and with type 2 diabetes, respectively. In a study of 1,407 participants lasting approximately a year and a half, patients treated with the 7.2 mg dose once weekly in combination with a healthy diet and physical activity reduced their body weight by an average of approximately one-fifth. About one-third of the treated patients achieved a reduction of 25% or more.

Body composition analysis shows that approximately 84% of the weight reduction is due to loss of adipose tissue, while muscle function is preserved. The most commonly reported adverse reactions were nausea, diarrhea, vomiting, and sensory disturbances, with symptoms being mild to moderate and transient in most cases.

Injectable Wegovy is already available in the EU in doses of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg, while the tablet form of the drug is available in the US and is awaiting a regulatory decision in the European Union.