Lilly rolls out oral GLP‑1 and faces FDA studies

Eli Lilly has started selling Foundayo, a once-daily obesity pill, across the United States less than two weeks after federal approval. (investor.lilly.com) Foundayo is Lilly’s brand name for orforglipron, a glucagon-like peptide-1 pill that targets the same appetite and blood-sugar pathway as blockbuster injections but comes as a tablet. The company said on April 9 that it is available through LillyDirect, telehealth providers and retail pharmacies nationwide. (investor.lilly.com) Lilly said Foundayo starts at $25 a month for some commercially insured patients and $149 a month for self-pay through LillyDirect. The company also said the pill can be taken any time of day without food or water restrictions. (investor.lilly.com) The Food and Drug Administration approved Foundayo on April 1 for adults with obesity, or overweight adults with weight-related medical problems, alongside diet and exercise. Reuters reported on April 14 that the agency also ordered Lilly to run post-marketing studies tied to safety questions around obesity pills in this class. (investor.lilly.com, reuters.com) Those studies will examine possible liver injury, cardiovascular events, delayed stomach emptying and effects during lactation, according to Reuters. Post-marketing studies are follow-up trials the Food and Drug Administration can require after approval to track risks that may not be fully answered in preapproval testing. (reuters.com) The launch gives Lilly a pill entry in a weight-loss market that has been dominated by weekly injections from Lilly and Novo Nordisk. CNBC reported on April 1 that Novo Nordisk’s oral Wegovy had reached the market about three months earlier, setting up a direct race in tablets as patients look for alternatives to shots. (cnbc.com) Lilly has pushed distribution beyond doctors’ offices by routing the drug through its own LillyDirect cash-pay channel and outside telehealth partners. HLTH and Fierce Healthcare both reported that the rollout includes digital-health services as Lilly tries to widen access quickly after launch. (hlth.com, fiercehealthcare.com) Lilly said Foundayo is the only glucagon-like peptide-1 pill for weight loss that does not require food or water timing rules, a practical difference from older oral diabetes drugs in the category. That convenience is now arriving with extra federal scrutiny, as the company sells the medicine at scale and prepares the studies regulators want next. (investor.lilly.com, reuters.com)