EMA panel recommends approval for Novo Nordisk’s new Wegovy 7.2 mg single-dose pen

DENMARK—Novo Nordisk has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Wegovy® 7.2 mg, a weekly injectable semaglutide treatment for adults with obesity.

The recommendation marks another step forward for the company as it expands its obesity treatment portfolio across global markets.

The latest development comes only weeks after Novo Nordisk reported encouraging topline findings from its phase 3a PIONEER TEENS trial, which evaluated oral semaglutide for the treatment of type 2 diabetes in children and adolescents aged 10 to 17 years.

The company has continued to strengthen its presence in both obesity and diabetes care as demand for GLP-1 medicines rises worldwide.

Higher-dose Wegovy shows strong weight loss results

Wegovy® 7.2 mg is already available in the European Union for adults with obesity through three separate 2.4 mg injections administered weekly.

The newly recommended single-dose pen is designed to make treatment more convenient for patients and healthcare providers.

The recommendation is based on findings from the STEP-UP clinical trial programme.

In the STEP-UP trial, participants with obesity who received semaglutide 7.2 mg achieved an average weight loss of 20.7%, and nearly one-third lost 25% or more of their body weight.

In the STEP UP T2D trial involving people with obesity and type 2 diabetes, participants recorded an average weight loss of 14.1%.

Researchers also confirmed that the safety and tolerability profile of the higher dose remained consistent with earlier semaglutide studies for weight management.

Mike Doustdar, president and chief executive officer of Novo Nordisk, said that Wegovy® has changed the lives of many people since its launch in 2021 by helping patients achieve substantial weight loss and improved cardiometabolic health outcomes.

He added that the higher 7.2 mg dose offers patients another option to help them reach their health goals with a simpler, easy-to-use single-dose pen.

Expansion beyond Europe and the US

The single-dose version of Wegovy® 7.2 mg has already secured approval in the United States and the United Kingdom.

In the US market, Novo Nordisk launched the treatment under the brand name Wegovy® HD earlier this year.

The US Food and Drug Administration approved the medicine in March 2026 after trial data showed an average weight loss of nearly 21% over 72 weeks.

Novo Nordisk also recently confirmed that Wegovy® HD is now available through more than 70,000 pharmacies across the United States, alongside access through telehealth providers and NovoCare® Pharmacy services.

Meanwhile, the company is preparing for broader international launches of its obesity treatments, including the oral Wegovy® pill, later in 2026 as competition intensifies in the global weight-loss drug market.

Novo Nordisk expects to launch Wegovy® 7.2 mg in the single-dose pen format across the European Union during the third quarter of 2026, pending final regulatory approval from the European Commission.