Europe’s medicines regulator has moved closer to approving a more powerful version of weight loss drug Wegovy, after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a 7.2 mg dose of the obesity treatment.
The decision puts the new dose on track to become a fresh option for people with obesity in the EU, promising even greater weight loss. Clinical trial data show the 7.2 mg dose delivered an average weight loss of 20.7% at 72 weeks in people with obesity who do not have diabetes.
The results build on Wegovy’s established benefits in obesity-related complications, including a significant reduction in the risk of cardiovascular events such as heart attack and stroke, as well as reduced pain from knee osteoarthritis.
The CHMP opinion is based on results from Novo Nordisk’s STEP UP and STEP UP T2D clinical trial programme, which studied semaglutide 7.2 mg in people with obesity with and without type 2 diabetes. Among participants without diabetes, one in three achieved weight loss of 25% or more at 72 weeks. Safety and tolerability were consistent with the currently approved 2.4 mg Wegovy dose.
Further analyses showed that 84% of the weight lost came from fat mass, while muscle function was preserved, addressing concerns about muscle loss during rapid weight reduction.
“This positive opinion means a new Wegovy option, delivering weight loss of 20.7%, could be available for people with obesity early in the new year, pending the European Commission’s final approval. Wegovy has proven health benefits in obesity, helping people reach their individual weight goals while preserving muscle function and reducing the risk of major cardiovascular events,” said Ludovic Helfgott, executive vice president and head of Product & Portfolio Strategy at Novo Nordisk.
“For those who want greater weight loss, there could soon be additional options with Wegovy so that even more people with obesity have the benefits that can improve their everyday lives and long-term health outcomes.”
Beyond Europe, Novo Nordisk is pushing ahead with regulatory filings in multiple markets. The company has applied to the EMA for a single-dose device to deliver the 7.2 mg formulation and confirmed that semaglutide 7.2 mg is under review in the US, UK and several other countries.
In the US, Novo Nordisk received the Commissioner’s National Priority Voucher and submitted the higher dose to the FDA in November 2025, a move expected to trigger an accelerated review within one to two months of acceptance.
If approved by the European Commission, the higher-dose Wegovy would mark a significant step in expanding treatment options for obesity, offering patients the prospect of greater, clinically meaningful weight loss without compromising muscle function.
