Novo Nordisk files high-dose Wegovy in EU

Novo Nordisk has moved quickly to file for approval of a new, higher-dose version of its obesity therapy Wegovy as it tries to fend off a growing challenge in the market from arch-rival Eli Lilly.

Data from two phase 2b trials of the 7.2mg formulation of GLP-1 receptor agonist Wegovy (semaglutide) has been submitted to the EMA in support of the application, one in people living with obesity and the other in subjects with obesity and type 2 diabetes.

According to the Danish pharma group, the results of the studies show that the new strength of Wegovy allowed around a third of patients to lose at least 25% of their body weight.

The phase 3b STEP UP obesity trial in more than 1,400 patients compared a 7.2mg weekly subcutaneous injection of semaglutide to the standard 2.6mg weekly dose sold as Wegovy or a matched placebo over 72 weeks.

Average weight loss was 20.7% with the 7.2mg dose, with the 2.6mg formulation achieving a 17.5% reduction and placebo a fall of 3.9% - based on patients who adhered to the weekly subcutaneous injections – with the tolerability of the stronger version "consistent" with the current product.

That is still lower than the average weight loss achieved in clinical trials of Eli Lilly's rival obesity therapy Zepbound (tirzepatide), a dual GLP-1/GIP agonist, which helped patients shed 20.9% of their weight at the same 72-week time point in its pivotal trial.

Zepbound has been making strong gains in the obesity market after outperforming Wegovy in the head-to-head SURMOUNT-5 trial. At the moment, the obesity market is effectively a duopoly, with Zepbound and Wegovy bringing in global sales of $2.31 billion and $2.64 billion, respectively, in the first three months of this year.

Lilly's drug grew more than fourfold compared to the same period of 2024, however, while Wegovy fell 13%, suggesting Zepbound has greater momentum in the market.

The high dose of Wegovy is one part of Novo Nordisk's plan to defend its obesity business, along with a major direct-to-consumer marketing drive for Wegovy and newer obesity candidates like CagriSema, which combines dual amylin and calcitonin receptor agonist cagrilintide with semaglutide, and dual GLP-1/amylin agonist amycretin.

Lilly, meanwhile, is developing an oral GLP-1 agonist, orforglipron, and posted the first positive phase 3 results with the programme in April.

"The submission of this new dose of Wegovy is another step forward in providing innovative solutions that meet the specific needs of people with obesity," said Novo Nordisk's head of product and portfolio strategy, Ludovic Helfgot.

"This new dose was developed as a tailored option for people in need of additional support to achieve meaningful, sustained weight loss," he added.

"With a reaffirmed safety and tolerability profile, we strongly believe in its potential to help even more people with obesity reach their individual weight loss as well as their broader health goals, including improvements in cardiovascular and kidney health, liver disease, type 2 diabetes, and mobility through knee osteoarthritis pain reduction."

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