Foundayo Launch & PMRs
- FDA approved Eli Lilly's oral obesity pill Foundayo, which exceeded 1,000 prescriptions in its first days on market. (pharmexec.com) (bonnercountydailybee.com) - FDA requested additional liver-safety data and mandated post-marketing cardiovascular studies for Foundayo. (tradersunion.com) - Approval accompanied by formalised follow-up underscores that launch can initiate structured post-market evidence obligations. (tradersunion.com)
Eli Lilly’s new obesity pill Foundayo reached 1,390 U.S. prescriptions in its first week, even as the Food and Drug Administration ordered more safety follow-up. (reuters.com) Foundayo, the brand name for orforglipron, won Food and Drug Administration approval on April 1 for adults with obesity or overweight with weight-related medical problems. Lilly said prescriptions were accepted immediately, with shipping through LillyDirect starting April 6. (investor.lilly.com) The first-week prescription count covered the week ended April 10, based on IQVIA data cited by Jefferies and reported by Reuters. Novo Nordisk’s oral Wegovy logged 3,071 U.S. prescriptions in its first four days after its January 5 launch, giving investors an early benchmark for the oral obesity-pill race. (reuters.com) Foundayo is a glucagon-like peptide-1, or GLP-1, pill, a class of drugs that helps control appetite and blood sugar. Lilly said it is the only approved GLP-1 weight-loss pill in the U.S. that can be taken without food or water restrictions, a convenience pitch aimed at patients who do not want injections. (investor.lilly.com) The approval letter shows the launch did not end the review. The Food and Drug Administration told Lilly to finish the ongoing ACHIEVE-4 trial and submit added safety data on major adverse cardiovascular events and possible drug-induced liver injury. (accessdata.fda.gov) The agency also required Lilly to run postmarketing studies in adolescents and to maintain a pregnancy exposure registry, which tracks outcomes when a drug is used during pregnancy after approval. Those obligations were listed alongside the approval in the formal letter posted by the regulator. (accessdata.fda.gov) The Food and Drug Administration approved Foundayo through the Commissioner’s National Priority Voucher pilot, a faster review pathway the agency said is meant for drugs judged important to public health or national security. Foundayo was the first new molecular entity approved under that pilot, according to the agency. (fda.gov) Lilly has tried to answer some of the safety questions quickly. Pharmaceutical Technology reported the company released more Foundayo data after the approval letter, while Endocrinology Advisor said the regulator had asked the company to study possible heart, liver and other risks tied to the drug. (pharmaceutical-technology.com) (endocrinologyadvisor.com) For now, Foundayo’s launch is moving on two tracks at once: commercial uptake in pharmacies and formal evidence collection after approval. The next milestones are more prescription data and the safety updates Lilly owes the Food and Drug Administration from ACHIEVE-4 and its postmarketing studies. (reuters.com) (accessdata.fda.gov)
