TLDR
- The FDA approved a higher 7.2mg dose of Novo Nordisk’s Wegovy weight loss injection on Thursday
- The new dose delivered average weight loss of 20.7% after 72 weeks, up from ~15% with the standard 2.4mg dose
- Novo plans to launch the higher-dose version in the U.S. in April
- The move is a direct response to competition from Eli Lilly’s Zepbound, which has taken market share from Wegovy
- This is the first drug approved under the FDA’s new national priority voucher program, which fast-tracks reviews to one to two months
Novo Nordisk is fighting back. After watching Eli Lilly’s Zepbound chip away at Wegovy’s market dominance, the Danish drugmaker got a boost Thursday when the FDA approved a higher-dose version of its blockbuster weight loss drug.
The new formulation contains 7.2 milligrams of semaglutide, injected once weekly. That’s a step up from the standard 2.4mg dose that launched Wegovy to fame. Novo expects to have it on shelves in the U.S. by April.
The approval came faster than usual. It was the first to go through the FDA’s new national priority voucher program, which aims to cut review times down to one to two months for drugs that support U.S. health priorities. The FDA launched that pilot in June.
In a phase three trial, patients using the higher dose lost an average of 20.7% of their body weight after 72 weeks. The standard Wegovy dose has typically shown around 15% average weight loss in trials.
For patients with obesity and Type 2 diabetes — a group that tends to lose less weight — the high-dose version still delivered 14.1% average weight loss in a separate phase three trial.
How This Stacks Up Against Zepbound
Lilly’s Zepbound has been pulling prescribers and patients away from Wegovy despite entering the U.S. market later. Its stronger efficacy profile has made it the go-to choice in the obesity space, and Lilly has cemented its position as the leading player.
Dr. Jason Brett, principal U.S. medical head at Novo Nordisk, said Thursday that the higher dose “reduces the delta” between Wegovy and Zepbound. He also pointed out that it gives patients another option if they’re not hitting their weight loss targets.
Novo Nordisk’s NVO stock was down about 1.88% Thursday.
What Else Is Going On at Novo
The approval comes at a tricky time for Novo. Last month, the company said U.S. sales were expected to decline this year due to both competition and lower drug prices. The company has announced plans to cut semaglutide prices in the U.S.
Earlier in March, Novo partnered with Hims & Hers Health to distribute its weight loss drugs through the telehealth platform, wrapping up a legal dispute between the two.
Eli Lilly (LLY) was down around 0.33% on Thursday. The company recently announced it will build a $6.5 billion manufacturing facility in Texas for its obesity pill and other drugs.
Roche is also eyeing the obesity market. The Swiss pharmaceutical company’s global head of cardiovascular and metabolism development said Roche sees the market splitting into segments based on how consumers access and pay for medicines.
Wegovy was first approved by the FDA in 2021 and has been central to Novo Nordisk’s growth since.
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