The Food and Drug Administration on Monday approved a pill version of the blockbuster weight-loss injectable drug Wegovy, offering patients who fear or are uncomfortable with needles a more palatable option.
The medication, simply called the Wegovy pill, will be available in the United States early next year. It is roughly as effective as the shot, data from a clinical trial sponsored by Novo Nordisk, the company that makes the drug, suggests. The pill contains a much larger dose of semaglutide, the compound that is in Wegovy and the diabetes drug Ozempic, than the shots because only a fraction of the substance is absorbed into the bloodstream when it is swallowed instead of injected.
There is already a form of oral semaglutide on the market, the diabetes drug Rybelsus. But the highest dose of Rybelsus is 14 milligrams, compared with the 25 milligrams in the maintenance dose of the Wegovy pill; people who take the Rybelsus pill usually lose much less weight than people who take the Wegovy or Ozempic shots.
Eli Lilly, the company that makes the competitor drugs Zepbound and Mounjaro, is expected to release its own weight-loss pill, orforglipron, around March.
In a clinical trial funded by Novo Nordisk, 205 participants took the Wegovy pill, and 102 took a placebo. Those on the Wegovy pill lost around 13.6 percent of their body weight, on average, after 71 weeks, compared with those in the placebo group, who on average lost a little over 2 percent of their body weight. Other trials have shown that adults who take injectable Wegovy lose around 15 percent of their body weight over a similar time period.
But results from carefully controlled studies don’t always translate to the messier real world.
“What we’re learning is the actual effectiveness of these drugs really are going to need to be determined by real-world evidence,” said Dr. David Kessler, a former commissioner of the Food and Drug Administration who has written a book about weight-loss drugs. “Trials always look better than they are in practice.”
In a deal with the Trump administration announced in November, Novo Nordisk said that it would charge $149 a month for the lowest dose of the Wegovy pill. Starter doses of this class of medications typically do not induce much weight loss but allow patients an on-ramp to build their tolerance to the drugs as they titrate up to the more potent doses.
Novo Nordisk did not announce additional pricing details on Monday.
The company is confident it will meet demand, David Moore, the executive vice president of Novo Nordisk’s U.S. operations, told The New York Times in an interview in October.
Many patients are likely to opt for a pill over a shot, doctors said: Some are wary of needles, and it may be easier to carry around pills than shots while traveling. But some doctors are skeptical that the Wegovy pill will be all that convenient in practice. You need to take the pill on an empty stomach, first thing in the morning — and not eat or drink anything for half an hour after.
“For me, there’s no way I’m going to take a pill and then not drink coffee for 30 minutes,” said Dr. Scott Hagan, an assistant professor of medicine at the University of Washington.
The Wegovy injectable is also approved to reduce the risk of heart attacks, strokes and other cardiovascular issues. In theory, the oral formulation should be able to confer those benefits, although regulators would need to weigh in on whether to clear the new pill for those purposes.
And despite the benefits, the medications are “not a cure-all,” Dr. Kessler stressed. “They’re not a panacea.”
In the clinical trial, people who took the Wegovy pill experienced roughly the same incidence of side effects as in past studies with the shot. Roughly 74 percent of people who took the pill experienced gastrointestinal side effects, compared to 42 percent of people who took the placebo.
Dani Blum is a health reporter for The Times.
The post F.D.A. Approves New Weight-Loss Pill appeared first on New York Times.
