Camilla Jessen
A new high-dose weight-loss injection has moved a step closer to wider use in the UK.
The UK Medicines and Healthcare products Regulatory Agency has approved a higher-strength version of semaglutide for people who struggle to lose weight on standard doses.
The approval follows clinical trial data reviewed by the regulator, according to The Telegraph.
The new option allows patients with a body mass index of 30 or higher to receive a once-weekly 7.2mg dose. This is three times the strength of the currently approved 2.4mg weekly dose.
MHRA guidance states that patients must first complete at least four weeks on the lower dose before becoming eligible.
Trial results
Approval followed results from the STEP UP clinical trial.
According to the findings, participants taking the 7.2mg dose alongside diet and exercise achieved an average weight loss of 20.7 percent.
Around one third of patients lost 25 percent or more of their body weight after 72 weeks. Those outcomes were higher than results seen in groups taking a placebo or the standard 2.4mg dose.
Reported side effects included nausea and stomach discomfort, particularly during the dose-increase phase.
What happens next
While MHRA approval clears an important regulatory hurdle, the treatment must still undergo a review by the National Institute for Health and Care Excellence. Until that process is complete, the higher dose will not be routinely prescribed on the NHS.
The findings come as Novo Nordisk, the manufacturer of Wegovy, has applied for approval of a single 7.2mg injection. Current guidance requires the dose to be delivered as three injections administered close together.
Industry response
Novo Nordisk welcomed the decision.
“This approval represents another important step in Novo Nordisk supporting people living with obesity to achieve meaningful and significant weight loss,” said Sebnem Avsar Tuna, the company’s UK general manager.
“The addition of a new dose of semaglutide provides healthcare professionals with greater flexibility to tailor treatment,” she added.
Sources: MHRA, The Telegraph, Novo Nordisk, The Lancet
