Novo Nordisk’s Wegovy (semaglutide injection) has received a new approval from the Medicines and Healthcare products Regulatory Agency (MHRA), this time for a 7.2mg dose designed for the weight management of adults with obesity.
The approval is based on data from the STEP UP trial. The trial demonstrated that a 7.2mg once-weekly maintenance dose had the ability to achieve more significant weight loss in people with obesity (defined as a BMI of over 30 kg/m2) if they were not reaching weight loss goals on a 2.4mg maintenance dose.
Trial results showed that patients receiving the 7.2mg dose of Wegovy achieved a weight loss of 18.7%, compared to 3.9% for patients receiving placebo. Likewise, it was also shown that with proper treatment adherence, the 7.2mg dose achieved weight loss of 20.7% after 72 weeks, compared to 2.4% on placebo. A third of trial participants receiving 7.2mg Wegovy lost 25% or more of their body weight compared to placebo. Participants of both the treatment and placebo arms also made lifestyle modifications as part of the trial.
Additionally, the trial showed a favourable tolerability profile for the increased dose, and side effects leading to discontinuation of treatment were balanced between the 2.4mg and 7.2mg treatment groups.
Obesity affects approximately 15 million people in the UK, with 71% of UK adults predicted to be obese or overweight by 2040.
Following the MHRA’s approval, eligible adult patients in the UK will be able to access the higher maintenance dose if they require further weight loss. The 7.2mg dose is currently available as three 2.4mg injections, but a 7.2mg single dose is expected to become available this year.
Sebnem Avsar Tuna, general manager of Novo Nordisk UK, said: “This approval represents another important step in Novo Nordisk supporting people living with obesity to achieve meaningful and significant weight loss.
“The addition of a new dose of semaglutide provides healthcare professionals with greater flexibility to tailor treatment for people living with obesity, supporting evidence-based approaches to improve health outcomes.”