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The basics:

• FDA reviewing Novo Nordisk‘s application for 25mg oral Wegovy
• Would establish first oral GLP-1 treatment for weight loss if approved
• Intended for adults with obesity and related comorbid conditions

The U.S. Food and Drug Administration has accepted Novo Nordisk’s application for an oral version of its blockbuster weight loss drug Wegovy.

The Danish drugmaker – which has its U.S. headquarters in Plainsboro – seeks regulatory approval for a once-a-day 25 milligram pill form of the semaglutide for chronic weight management, according to a May 2 press release.

If the FDA signs off on the application, the company’s experimental once-daily version will become the first oral GLP-1 for weight loss. According to Novo Nordisk, the treatment is intended to minimize the risk of major adverse cardiovascular events for adults who are obese or overweight with one or more comorbid condition.

Currently, the therapy is approved as a 2.4 mg dosage injection for use alongside a low-calorie diet and increased physical activity in adults as well as pediatric patients aged 12 and up who have weight-related medical problems.

Additionally, adults who are obese or overweight with a history of heart disease use Wegovy to help diminish the risk of cardiovascular incidents, such as heart attacks, strokes or mortality.

Novo Nordisk said it expects a decision by the fourth quarter of this year.

The pharma giant already has one GLP-1 available in pill form under the name Rybelsus. The FDA cleared that drug in 2019 for blood sugar control in adults with diabetes.

‘New era of obesity care’

Anna Windle is Novo Nordisk’s senior vice president of clinical development and medical & regulatory affairs. In a statement, she said, “We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations.”

“Novo Nordisk’s strong legacy in obesity care and decades of scientific research and innovation have brought us to this moment. We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity,” she said.

Compared with injectables, oral medications are cheaper to manufacture and generally easier for patients to administer. As such, pharma companies are racing to bring a weight loss pill to market.

Eli Lilly recently said it expects its candidate to secure FDA approval in 2026. Roche and AstraZeneca are also tying to develop oral GLP-1s for weight loss.

However, Pfizer halted efforts on its pill last month, effectively dropping out of the race. The move came after seeing signs of liver toxicity in late-stage clinical testing, BioPharma Dive reported.