Lilly rolls out oral GLP‑1, FDA asks for studies

Eli Lilly has started selling its new obesity pill, Foundayo, across the United States as the Food and Drug Administration orders follow-up safety studies. (accessdata.fda.gov) Foundayo, the brand name for orforglipron, became available on April 9 through LillyDirect, telehealth providers and retail pharmacies after the Food and Drug Administration approved it on April 1 for adults with obesity or overweight plus a weight-related condition. (investor.lilly.com) Lilly said the pill is shipping nationwide and can be ordered through channels including Amazon Pharmacy, Ro, Weight Watchers Med+ and GoodRx, alongside LillyDirect’s home-delivery service. (hlth.com) Glucagon-like peptide-1 drugs mimic a gut hormone that helps people feel full and eat less. Foundayo is a once-daily tablet taken with or without food, unlike the weekly injections that have dominated the obesity market. (pi.lilly.com) The Food and Drug Administration’s approval letter requires Lilly to run clinical trials after launch to assess signals for drug-induced liver injury, major adverse cardiovascular events, retained gastric contents and exposure during lactation. (accessdata.fda.gov) Those studies arrive as Lilly pushes a broader commercial strategy around convenience and price. The company said eligible commercially insured patients may pay as little as $25 a month, while self-pay pricing starts at $149 a month at the lowest dose. (investor.lilly.com) The pill’s selling point is flexibility. Lilly says Foundayo is the only weight-loss glucagon-like peptide-1 pill that can be taken any time of day without food or water restrictions. (investor.lilly.com) In Lilly’s Phase 3 ATTAIN-1 study, patients on the highest dose who stayed on treatment lost an average of 27.3 pounds, or 12.4% of body weight, at 72 weeks, compared with 2.2 pounds on placebo. (investor.lilly.com) The label still carries the class’s familiar cautions. Foundayo has a boxed warning about thyroid C-cell tumors seen in rodents, and the prescribing information also warns about pancreatitis, severe gastrointestinal reactions and kidney injury tied to dehydration. (pi.lilly.com) Lilly is opening the oral front of the obesity drug fight just months after Novo Nordisk brought an oral Wegovy to market. The next test is whether a daily pill with easier dosing can expand use while Lilly completes the safety studies the regulator now wants. (cnbc.com)