The U.S. Food and Drug Administration (FDA) said on the 1st (local time) it has approved Foundayo (ingredient name Orforglipron), an oral obesity treatment from U.S. pharmaceutical company Eli Lilly and Company.
The glucagon-like peptide (GLP)-1 class of obesity treatments that have taken the global market by storm are now available as a once-daily pill, following once-weekly injections. Competition among obesity-drug corporations is expected to intensify.
Foundayo was approved for weight loss and long-term maintenance in adults with obesity or overweight (with at least one weight-related comorbidity) in combination with diet and exercise. Dosing starts at 0.8 mg and can be titrated stepwise up to a maximum of 17.2 mg.
Efficacy was also 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 effect compared with placebo.
Earlier, Novo Nordisk launched the oral obesity treatment "oral Wegovy (ingredient name semaglutide)" in January and has been focused on expanding market share.
Lilly emphasized product competitiveness that differs from Wegovy for Foundayo. The company said Foundayo is the only oral GLP-1 obesity treatment 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. That significantly moved up the expected approval timing, which under the existing Prescription Drug User Fee Act (PDUFA) schedule had been projected for January next year, and the FDA said it is the fastest approval among new molecular entities (NME) since 2002.
Distribution in the United States will proceed quickly. Foundayo can be prescribed immediately through the company's platform (LillyDirect), and shipments will begin on the 6th. Supply will then expand through U.S. retail pharmacies and telemedicine channels.
Prices in the United States vary depending on insurance coverage. Private insurance enrollees can access it at about $25 per month, while out-of-pocket patients start at $149 per month. Medicare Part D beneficiaries can access it at about $50 per month starting in July.
Industry observers are watching the possibility that the center of gravity in the obesity-drug market could shift from injectables to orals with this approval. Compared with injectables that require cold-chain (refrigerated distribution), oral obesity drugs can be stored at room temperature and offer greater dosing convenience, which can significantly improve patient adherence, leading to their evaluation as "game changers."
Some also say the arrival of relatively lower-priced orals could catalyze full-fledged debate on expanding insurance coverage by viewing obesity as a chronic disease like diabetes and hypertension. The World Health Organization (WHO) last year issued its first global guideline recommending GLP-1 class drugs for obesity treatment, and some countries are recognizing obesity as a chronic disease, spurring policy changes.
The launch date in Korea for the oral obesity drug is undecided. It requires approval from the Ministery of Food and Drug Safety and price negotiations. Eli Lilly and Company CEO David Ricks said, "It will be suitable not only for weight loss but also for patients aiming to maintain weight," adding, "We have filed for approval in more than 40 countries."
A Korea Bio Association official said, "If oral GLP-1 treatments with dosing convenience and price competitiveness spread, market access will improve significantly," adding, "Whether insurance coverage is provided will be the key variable determining the pace of future market growth."