Today, FDA approved Lilly’s GLP-1 oral tablet as the first approval of a new molecular entity (NME) through the CNPV program. The FDA says the drug Foundayo (orforglipron), “was approved 50 days after the NDA was filed and 294 days before the application’s PDUFA date of January 20, 2027”. According to the FDA (here), commissioner Makary praised the FDA’s fast and complete review of the application saying “[B]y cutting idle time and maintaining constant communications with the company throughout the review process, we completed this national priority review with outstanding efficiency, while upholding the FDA’s gold-standard science. This reflects the level of performance the public should expect from the FDA.”
The notice cited above provides information on the two randomized double-blind clinical studies that supported approval of the NDA. Basic information on side effects and warnings for the drug including a “boxed warning thyroid C-cell tumors”.
There has been considerable controversy regarding the CNVP program and the transparency of the selection process for candidates for the vouchers. The FDA is holding a “public meeting on June 4 (rescheduled from June 12) to solicit feedback about the CNPV program’s eligibility criteria, the voucher selection process, sponsors responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV review council, and program implementation. Interested parties may also submit written comments through June 29, 2026.”
