FDA approves another GLP-1 pill for weight loss

“People living with obesity need treatment options that meet them where they are—and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment,” Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston, said in prepared remarks. “With Foundayo, we now have an oral option that delivered an average of 12.4% weight loss at the highest dose in clinical trials—addressing both the clinical realities of obesity and the practical challenges patients face every day.”

“We believe Foundayo can help level the playing field for those living with obesity or who are overweight and living with weight-related complications,” added David A. Ricks, chair and CEO of Eli Lilly and Company. "As a convenient, once-daily oral pill that delivers meaningful weight loss, this is obesity care designed for the real world.”

FDA’s approval was part of new pilot program

The FDA’s decision to approval orforglipron was made as part of the Commissioner's National Priority Voucher (CNPV) Pilot Program, a new pathway for expediting the approval of certain therapies that “address critical national health priorities.” Companies chosen for this program receive a voucher that entitles them to certain benefits, including improved communication with federal regulators and a faster review process. 

This represents the fifth approval the FDA has granted under the CNPV program. The fourth approval under the program was for a higher dose of Novo Nordisk’s semaglutide injections.

According to the FDA, orforglipron was approved faster than any new molecular entity since 2002. 

“This approval demonstrates what the FDA can achieve when we eliminate delays and prioritize fast and thorough work from the agency and industry partners,” FDA Commissioner Martin Makary, MD, MPH, said in an agency statement. “By cutting idle time and maintaining constant communications with the company throughout the review process, we completed this national priority review with outstanding efficiency, while upholding the FDA’s gold-standard science. This reflects the level of performance the public should expect from the FDA.”

Novo Nordisk responds to approval with news of its own

Novo Nordisk, clearly fighting to stay ahead in the oral GLP-1 market, announced new data from a population-adjusted indirect treatment comparison of oral semaglutide and orforglipron. The findings, scheduled to be presented during the Obesity Medicine Association’s annual conference, link oral semaglutide to significantly more weight loss than orforglipron as well as a lower risk of stopping the medication due to gastrointestinal issues.

“People often ask how one medication compares to another when making obesity treatment management decisions,” Robert F. Kushner, MD, a nutrition specialist with Northwestern Feinberg School of Medicine, said in a statement. “Since there are no head-to-head trials comparing oral semaglutide for obesity to orforglipron, this indirect treatment comparison from the ORION study provides important information that can be used during the shared decision-making process.”