The Food and Drug Administration has approved a high-dose version of Novo Nordisk’s obesity drug Wegovy, giving the Danish pharmaceutical company another chance to claw back market share it lost to its top rival.
The agency on Thursday cleared “Wegovy HD,” a once-weekly injection of a 7.2 milligram dose of Novo’s popular weight loss medicine. That dose is three-fold higher than the 2.4 milligram injection Wegovy recipients begin receiving after a multimonth ramp-up period. It’s been cleared for certain adult patients to reduce excess body weight and keep weight down over the long-term.
The approval is the fourth handed out under a new FDA voucher program meant to drastically speed up the reviews of medicines that align with “national interests.” That program cuts drug evaluations to as little as one to two months and, in Novo’s case, led to an approval only 54 days after an application was filed. But the initiative has drawn criticism for its potential to be used as a tool to curry political favor. Novo was awarded that voucher only after cutting a deal with the White House in November to lower the prices of its obesity medicines.
Still, the clearance gives Novo another way to battle Eli Lilly for superiority in the ultra-lucrative market for weight loss medicines. Novo was once the leader, having brought Wegovy to market in the U.S. in June 2021, more than two years before Lilly’s rival Zepbound arrived. But Zepbound proved more powerful in spurring weight loss than Wegovy and even succeeded in a head-to-head trial in 2024. Since then, Lilly has carved away at Novo’s position and now claims more than 60% of the U.S. market.
A combination of pricing pressure and competition from compounders has also chipped away at Novo’s sales, triggering an executive shakeup and dimming financial outlook that have depressed its share price. A next-generation weight loss drug it’s working on disappointed investors as well. The situation has left Novo with a “pressing need for M&A,” wrote Jefferies analyst Michael Leuchten, in a note to investors last month.
Yet the company is ahead of Lilly in bringing to market a pill form of Wegovy that’s off to a fast sales start. Now it’s adding a high-dose form of its injectable medication that’s produced stronger weight loss results than the original and comparable to what was observed in testing of Zepbound.
In one large trial for obesity, people given high-dose Wegovy lost, on average, 20.7% of their body weight after 72 weeks, versus 17.5% among those on the previously approved dose. One-third of those on the high dose achieved greater than 25% weight loss, too. High-dose Wegovy was associated with an average weight loss of 14.1% in a second study in people with Type 2 diabetes and obesity. Safety was “comparable” to what was observed in previous testing of Wegovy, Novo said.
Novo will launch the new version in the U.S. in April. It’s already cleared for use in Europe and the U.K.
