The Food and Drug Administration on Monday approved an oral version of Novo Nordisk’s weight-loss drug Wegovy, triggering the next phase of a high-stakes battle with rival Eli Lilly for control of the lucrative anti-obesity drug market.
The approval marks a paradigm shift in the treatment of obesity. Currently, the market is dominated by weekly injections that can cause significant weight loss. The pills for these medications appear to be somewhat less potent, but they are more convenient to take and could substantially expand their use. Combination, injectable and oral medications of this “GLP-1” class are Wall Street analysts expect it to generate annual sales of more than $100 billion. by 2030.
Novo will have a head start with Wegovy oral, which will launch in early January. But this could quickly be joined by Eli Lilly’s experimental pill, orforglipron, which was successful in recent trials this year and may be approved within weeks. thanks to a “national priority” bonus granted by the FDA.
“The pill is here,” Novo CEO Mike Doustdar said in a statement. “No other current oral GLP-1 treatment can match the weight loss produced by the Wegovy pill, and we are very excited about what this will mean for patients in the US.”
Under pressure from President Trump, the FDA and other federal health agencies have been intensely focused on expanding the number of and access to obesity medications available. Novo and Lilly also reached deals with the White House to lower their drug prices for some Medicare beneficiaries and those willing to pay cash. As part of those negotiations, they also agreed to price initial doses of their oral medications at $149 per month.
For Novo, the arrival of oral Wegovy comes after a series of setbacks that have depressed its share price and caused the company to lose its leadership position to Lilly. It is also the result of a strategic change. The Wegovy pill, a higher-dose version of an oral GLP-1 sold as Rybelsus for diabetes, successfully concluded multiple Phase 3 trials in 2023. But Novo shelved regulatory filings at the time as it struggled to meet growing demand for GLP-1 drugs.
Novo had also prioritized a experimental dual-action injectable drugjust to see that therapy and another perspective of oral drug generate disappointing study data. Although that dual-action drug, CagriSema, has already been submitted to regulators, Novo has also accumulated more data on Wegovy oral and advanced with a presentation.
Novo’s Phase 3 trials, called OASIS, tested oral Wegovy at doses reaching 50 milligrams per day. The latest to report results, OASIS-4, showed that the 25 milligram dose approved Monday helped people who were obese or overweight and related health complications. lose an average of 14% of your body weight for 71 weeks, or 17% in those who fully adhered to treatment plans.
Over the course of a week, seven daily doses of 25 milligrams of one Wegovy pill would be equivalent to more than 50 times the 2.4 milligrams contained in the highest dose of the weekly injection. This difference is necessary for difficulty administering a peptide drug like Wegovy through the digestive system.
By comparison, orforglipron is a chemical or “small molecule” drug that requires less complex manufacturing. In clinical trials, the The highest daily dose tested was 36 milligrams..
