By Louise Rasmussen
COPENHAGEN (Reuters) -Novo Nordisk said on Monday data from a late-stage trial showed an oral version of its drug semaglutide for weight loss helped overweight or obese adults lose on average between 15-17% of their body weight, comparable to its Wegovy injection.
The results are another boost for Novo Nordisk whose weekly Wegovy injection has transformed the weight-loss market since its U.S. launch in June 2021, capturing the attention of patients, investors and even celebrities worldwide.
The Danish drugmaker said in a statement that the headline results were statistically significant and showed superior weight loss when compared to a placebo.
It expects to file an application for the daily tablet for regulatory approval in the United States and the European Union in 2023.
A global launch of the oral 50 milligram (mg) semaglutide drug is contingent on portfolio prioritisations and manufacturing capacity, the company added without giving further details.
The Phase IIIa study within the so-called OASIS programme involved 667 adults with obesity or who were overweight with one or more comorbidities. The treatment was in conjunction with lifestyle intervention.
Participants who adhered to the treatment on average experienced a weight loss of 17.4% after 68 weeks compared with only 1.8% of the those that took the placebo, Novo said.
Those participants who didn't fully adhere to the treatment achieved a weight loss of 15.1% compared to a reduction of 2.4% with placebo.
The results are comparable to the company's Wegovy injection, said Martin Holst Lange, head of development at Novo Nordisk. That leads to around 15% weight loss on average, alongside diet and exercise changes.
"The choice between a daily tablet or weekly injection for obesity has the potential to offer patients and healthcare providers the opportunity to choose what best suits individual treatment preferences," he added.
While widely expected, the result of the study was a reassuring outcome given the threats of future competitive drugs, Jefferies wrote in a note to clients.
Sales of the 50 mg drug could rise to $8 billion a year, the brokerage estimated.
The drug appeared to have a "safe and well-tolerated profile", with the most common adverse impact being mild to moderate gastrointestinal effects that diminished over time, Novo Nordisk said.
Novo Nordisk has had supply issues and struggled to keep up with soaring U.S. demand for Wegovy. The lowest dose of the weekly Wegovy injection contains just 2.4 mg of semaglutide, while the daily pill contains 50 mg.
A spokesperson declined to comment on manufacturing capacity of the pill, but the company is prioritising U.S. supplies of Wegovy over launching in new markets.
(Reporting by Louise Breusch Rasmussen; additional reporting by Boleslaw Lasocki and Maggie Fick; editing by Terje Solsvik, Paul Simao and Conor Humphries)