Eli Lilly’s Foundayo (orforglipron) got FDA approval in 50 days. That’s 294 days ahead of its January 2027 PDUFA date and the fastest new molecular entity approval since 2002.
The approval is the first NME greenlit under the Commissioner’s National Priority Voucher program, a pilot launched in 2025 to fast-track drugs addressing critical national health priorities. Eighteen vouchers awarded. Six decisions issued. Foundayo is the fifth CNPV approval overall, but the first for a new molecular entity. It’s an oral GLP-1 receptor partial agonist — a once-daily pill that doesn’t require injection or an empty stomach, which sets it apart from the injectable semaglutide products dominating the obesity market.
If the CNPV program holds at this pace, the standard 12-month review clock is no longer the assumed baseline for drugs that earn a voucher. Competitors across the GLP-1 space and every other category angling for national priority status now have a real reason to rethink their FDA communications strategy. The agency’s stated target under the program is two months. Lilly hit it.
The FDA’s public meeting on the CNPV program is rescheduled from June 12 to June 4, with written comments accepted through June 29.