FDA Clears First Weight-Loss Pill as Obesity Treatment
U.S. regulators have authorized the first pill taken by mouth to treat obesity, opening the door to a new option for patients who until now needed injections to access GLP-1 weight-loss therapies. The Food and Drug Administration signed off on the drug Monday after studies showed meaningful weight reduction along with heart-health benefits, according to its manufacturer, Novo Nordisk.
The newly approved tablet is designed to be taken once a day and uses semaglutide, the same compound found in the company’s injectable Wegovy and Ozempic. It is the first oral GLP-1 receptor agonist approved in the United States for long-term weight management.
Approval covers adults with obesity, as well as those who are overweight and have at least one related medical condition such as heart disease, provided the medication is used alongside diet and exercise.
Clinical results played a central role in the decision. In the OASIS 4 phase 3 study, participants taking a 25-milligram daily pill shed an average of 16.6% of their body weight over 68 weeks, while those given a placebo lost 2.7%. Novo Nordisk said roughly one in three patients in the treatment group dropped at least 20% of their body weight.
The FDA’s decision was also backed by findings from the large SELECT trial, which showed that semaglutide lowered the risk of major cardiovascular events, including heart attack and stroke, in adults with obesity or overweight who already had cardiovascular disease.
Until this approval, all FDA-cleared GLP-1 medications for weight loss were delivered by injection. Drugs in this class work by mimicking a hormone that helps control appetite and slows digestion, allowing patients to feel full for longer periods.
“With today’s approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” Mike Doustdar, president and CEO of Novo Nordisk, said in a news release. “As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight-loss journey.”
Novo Nordisk has indicated that the drug could enter the U.S. market at an initial price of about $149 for a month’s supply, far less than many injectable GLP-1 treatments that can run uninsured patients hundreds of dollars each month.
The company has argued that pills may be easier for insurers to cover than injections, potentially broadening access for people who have avoided shots or encountered insurance barriers.
Investors responded quickly to the announcement, pushing Novo Nordisk shares up more than 9% in after-hours trading on news of the approval and the company’s first-mover advantage in oral obesity treatment.
The manufacturer said it plans to roll out the Wegovy pill in the United States in early January and has already submitted the medication for regulatory review in Europe and other regions.
The approval arrives as competitors move closer to the same space. Eli Lilly and Company is developing its own once-daily oral weight-loss drug, orforglipron, which has delivered double-digit percentage weight loss at higher doses in late-stage trials and met key study goals. The company is expected to seek FDA clearance next year, setting up a head-to-head race in what analysts see as a future multi-billion-dollar global market.
Like other semaglutide-based products, the Wegovy pill carries warnings about gastrointestinal side effects and includes a boxed warning tied to thyroid tumors observed in animal studies.
{Matzav.com}
