The U.S. Food and Drug Administration (FDA) said on the 1st (local time) that it has approved Foundayo (ingredient name Orforglipron), an oral obesity treatment from U.S. pharmaceutical company Eli Lilly and Company.
After weekly injections, the glucagon-like peptide (GLP)-1 class of obesity drugs that has taken the global market by storm is now available as a once-daily pill. Competition among obesity drug corporations is expected to intensify.
Foundayo was approved for adults with obesity or overweight (with at least one weight-related comorbidity) to be used with diet and exercise for weight loss and long-term maintenance. Dosing starts at 0.8 mg and can be titrated stepwise up to a maximum of 17.2 mg.
Efficacy was demonstrated in clinical trials. In two randomized, double-blind, placebo-controlled studies in adults with obesity or overweight, 72 weeks of treatment showed that the Foundayo group achieved a statistically significant weight loss compared with placebo.
Earlier, Novo Nordisk launched the oral obesity drug "Wegovy (ingredient name semaglutide)" in Jan., focusing on expanding its market share.
Lilly emphasized product competitiveness that sets Foundayo apart from Wegovy. The company said Foundayo is the only oral GLP-1 obesity drug that can be taken regardless of food or water intake or dosing time. Oral Wegovy must be taken on an empty stomach.
This FDA approval is the fifth case under the "CNPV (Commissioner's National Priority Voucher)" program and came just 50 days after the application was filed. The FDA said this significantly moved up the anticipated approval date, which under the existing Prescription Drug User Fee Act (PDUFA) timeline had been expected in Jan. next year, making it the fastest approval among new molecular entities (NMEs) since 2002.
U.S. distribution will also proceed quickly. Foundayo is immediately available for prescription intake through the company's platform (LillyDirect), with deliveries beginning on the 6th. Supply will then expand through retail pharmacies and telehealth channels in the United States.
Pricing in the United States varies depending on insurance coverage. Private insurance enrollees can access it for about $25 per month, while out-of-pocket patients start at $149 per month. Those covered under the public Medicare Part D program can access it for about $50 per month starting in Jul.
Industry watchers are focusing on the possibility that the center of gravity in the obesity drug market could shift from injections to oral medications with this approval. Compared with injections that require a cold chain, oral obesity pills can be stored at room temperature and offer greater dosing convenience, which can markedly improve patient adherence, earning them the label of a "game changer."
With the emergence of relatively lower-priced oral drugs, some analysts say discussions on expanding insurance coverage could ramp up as obesity is treated as a chronic disease like diabetes and hypertension. The World Health Organization (WHO) last year issued its first global guidelines recommending GLP-1 medications for obesity treatment, and some countries are enacting policy changes such as officially recognizing obesity as a chronic disease.
The launch date for oral obesity drugs in Korea is undecided. Approval by the Ministery of Food and Drug Safety and reimbursement negotiations are required. Eli Lilly and Company CEO David Ricks said, "It will be suitable not only for patients aiming for weight loss but also for those aiming for maintenance," adding, "We have filed for approval in more than 40 countries."
A Korea Biotechnology Industry Organization official said, "If oral GLP-1 therapies with dosing convenience and price competitiveness spread, market access will improve significantly," adding, "Whether insurance coverage is granted will be the key variable that determines the pace of market growth."