The “oral obesity drug” race has begun.

According to Reuters and other foreign media on the 2nd (local time), the US Food and Drug Administration (FDA) on the 1st approved Eli Lilly’s oral obesity treatment “Poundayo (orforglipron).” Following Novo Nordisk’s launch of oral Wegovy at the beginning of the year, Lilly has now joined the fray, and the obesity treatment market is seen as shifting from injectable formulations to a competition in pill form, entering a “second round.”

● Ultra-fast approval in 50 days… Emphasis on convenience of dosing

Poundayo, newly approved by the FDA, is a once-daily pill that targets the glucagon-like peptide-1 (GLP-1, a type of hormone that lowers blood glucose and maintains satiety) receptor. It can be prescribed for adults who are overweight or obese and have at least one weight-related comorbidity. Under the Critical National Priorities Voucher (CNPV) program, approval was granted just 50 days after the submission of documentation, marking the fastest approval for a new molecular entity (NME) since 2002.

Lilly is highlighting the convenience of Poundayo, which needs to be taken “just once a day at any time.” Novo Nordisk’s oral Wegovy (semaglutide) must be taken in the morning immediately upon waking, on an empty stomach, with a specified amount of water, and for the next 30 minutes intake of food, water, and other medications is strictly restricted. In contrast, as a small-molecule drug, Poundayo can be taken regardless of meals, water intake, or time of day.

Price competition is also intense. Lilly has set the out-of-pocket price for a one-month supply of the lowest dose of Poundayo at USD 149 (about KRW 200,000, roughly USD 5 per day). In effect, the company is promoting it as a way to address obesity at about the price of a cup of coffee. For those with commercial insurance, the monthly cost drops to USD 25 (about KRW 34,000), putting it on par with Novo Nordisk’s oral Wegovy.

A war of nerves over efficacy is also intensifying. According to Lilly’s clinical trial results, patients who took the highest dose of Poundayo for 72 weeks recorded an average weight reduction of 12.4% (27.3 pounds). Novo Nordisk’s Wegovy tablet won US approval based on data showing an average 16.6% weight loss among patients who adhered to treatment.

Poundayo will begin shipping from the 6th via Lilly’s direct-to-consumer platform “LillyDirect,” after which the company plans to expand distribution through retail pharmacies and telehealth providers. The launch timing of these oral obesity treatments in Korea remains undecided, but in the past, it took about 22 months for the injectable “Wegovy” to obtain product approval from Korea’s Ministry of Food and Drug Safety following FDA approval.

● Ildong in Phase 1, Hanmi in Phase 3… Fierce pursuit by Korean pharma

As the global obesity treatment market rapidly reorganizes around convenient oral formulations, leading Korean pharmaceutical companies are intensifying their pursuit. Ildong Pharmaceutical has completed Phase 1 clinical trials for a small-molecule oral obesity treatment candidate and is preparing to enter Phase 2 to demonstrate global competitiveness. Dong-A ST is scheduled to unveil a new research and development (R&D) strategy in May and is reportedly reviewing plans to expand development of its subsidiary Metabia’s MASH (metabolic dysfunction-associated steatohepatitis, formerly nonalcoholic steatohepatitis) treatment candidate “Banoglifel (DA-1241)” into an oral obesity therapy. Hanmi Pharmaceutical’s injectable obesity drug “efpeglenatide” has shown a significant weight loss effect in domestic Phase 3 trials and is nearing commercialization. The company also plans to diversify beyond injectables into next-generation oral obesity drugs.

An executive at a domestic pharmaceutical company said, “As a speed race unfolds in the development of oral obesity drugs, the fact that another big pharma has secured FDA approval is positive in terms of expanding the relevant market,” but added, “From the perspective of Korean pharmaceutical firms, there is a strong sense of crisis that if they fail to narrow the R&D gap, they could quickly fall behind in the market.”

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