European regulators to approve Wegovy 7.2 mg in a single-dose pen and Wegovy pill

Novo Nordisk has announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation of Wegovy 7.2 mg (once-weekly injectable semaglutide 7.2 mg) in a single-dose pen and Wegovy pill.

Wegovy 7.2 mg is already available in the EU for adults with obesity, dosed as three injections of 2.4 mg, and is based on results from the STEP UP trial programme. In the STEP UP trial, semaglutide 7.2 mg injected once weekly demonstrated 20.7% mean weight loss in participants with obesity, and approximately one in three people experienced 25% or greater weight loss. In the STEP UP T2D (type 2 diabetes) trial, in participants with obesity and type 2 diabetes, semaglutide 7.2 mg demonstrated a mean weight loss of 14.1%1. In both trials, the well-known safety and tolerability profile of semaglutide was reaffirmed with semaglutide 7.2 mg, which was comparable to previous trials with semaglutide for weight management.

Wegovy 7.2 mg in the single-dose pen is already approved in the US and UK. In the US, Wegovy 7.2 mg is launched under the brand name Wegovy HD. Novo Nordisk expects to launch Wegovy 7.2 mg in a single-dose pen in the EU in the third quarter of 2026.

The STEP UP and STEP UP T2D phase 3 trials investigated the efficacy and safety of injectable semaglutide 7.2 mg in people with obesity without or with type 2 diabetes. The 72-week STEP UP trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo as an adjunct to lifestyle intervention. The trial included approximately 1,400 adults with obesity. The 72-week STEP UP T2D trial evaluated the efficacy and safety of injectable semaglutide 7.2 mg compared to placebo in approximately 500 adults with obesity and type 2 diabetes.

Wegovy pill

CHMP has also adopted a positive opinion, recommending marketing authorisation of Wegovy pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain long-term weight reduction. The positive opinion also includes SELECT data in the label, demonstrating that Wegovy reduces the risk of major adverse cardiovascular events (MACE).

Wegovy pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy recommended for approval by CHMP for weight management in the EU. The recommendation is based on the OASIS trial programme and the SELECT2 trial. In the OASIS 4 trial, oral semaglutide 25 mg taken once daily demonstrated 16.6% mean weight loss when treatment was adhered to in adult participants with obesity or overweight with one or more comorbidities. The weight loss achieved with Wegovy pill is similar to that of injectable Wegovy 2.4 mg. Furthermore, one in three people experienced 20% or greater weight loss in the OASIS 4 trial.

The well-known safety and tolerability profile of semaglutide was reaffirmed with Wegovy pill in the OASIS 4 trial, which was comparable to previous semaglutide trials for weight management. Semaglutide is supported by more than 50 million patient-years of real-world safety data, and notably, the Wegovy pill label includes no drug–drug restrictions with concomitant medications.

“We are encouraged by CHMP’s positive opinion for Wegovy pill, bringing the most efficacious oral GLP-1 in its class one step closer to becoming the first approved oral treatment in its class for weight management in the EU”, said Mike Doustdar, president and CEO of Novo Nordisk. “The demand for effective and convenient obesity treatment is already evident in the US, where more than 1 million Americans began using Wegovy pill within the first four months following launch. We look forward to bringing this innovative medicine to the first markets outside the US in the second half of 2026.”