FDA approves Novo Nordisk's oral GLP-1 for weight loss

The FDA has approved Novo Nordisk’s once-daily Wegovy pill, the first oral GLP-1 medicine for obesity in the US. The Wegovy pill can be used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. The pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke in adults with overweight or obesity and established cardiovascular disease.

The FDA approval of Wegovy pill is based on the results from the OASIS 4 phase 3 clinical trial, which was a 64-week medical study that included 307 adults with obesity or overweight with one or more weight-related comorbidities, without diabetes.

Results showed that if all patients stayed on treatment, people taking Wegovy pill once-daily along with a reduced calorie diet and exercise achieved an average weight loss of about 17% (16.6%) versus about 3% (2.7%) with placebo. When looking at the efficacy regardless of if all patients stayed on treatment, an average weight loss of about 14% (13.6%) was achieved by people taking Wegovy pill compared to about 2% (2.4%) for placebo.

For Wegovy pill based on baseline body weight of 235 lb and for placebo based on baseline body weight of 231lbs. In OASIS 4, common adverse reactions were similar to those previously seen in clinical trials with Wegovy (semaglutide) injection 2.4 mg, including nausea, diarrhoea, and vomiting.

"With more choices, HCPs are better equipped to tailor treatment approaches and support patients who want to gain control of their weight, and this milestone approval underscores exactly that kind of choice," explained Dr Timothy Garvey, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. "The availability of Wegovy pill expands the possibilities for weight management with semaglutide, giving healthcare professionals a powerful, efficacious medicine in a new method of delivery, allowing the ability to help meet more patients where they are."

The starting dose of 1.5 mg will be available in pharmacies and select telehealth providers in early January with savings offers for $149 per month.

"After many years advocating for people living with obesity, one thing has always been clear: patient safety has to come first. That's why it's critical we rely on treatments that are rigorously tested and FDA-approved," said Joe Nadglowski, president and CEO of the Obesity Action Coalition. "A brand new effective pill for weight loss gives people greater flexibility to choose a GLP-1 treatment that can fit in their daily routine and preferences."

“Now, with Wegovy pill, we are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials. We are confident that the expansion of Wegovy to a pill will help patients who may have not sought or accepted treatment before," said Dave Moore, executive vice president, US Operations at Novo Nordisk. "Wegovy pill is the next chapter in our decades-long GLP-1 experience - supported by the most affordable self-pay price to date in a GLP-1 for obesity. We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities."