Only 23 days from NDA submission to FDA approval, an unnoticed record.
On Wednesday July 15th, Merck received FDA approval for Lipfendra (enlicitide) tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). This is the first approval for an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, existing treatment options in this class have all been injectable.1
A Commissioner's National Priority Voucher (CNPV) had been issued to Merck for enlicitide back in December 2025.2 The CNPV pilot program, announced in June 2025, is a voucher program designed to accelerate review of products that align with U.S. national health priorities, aiming to compress review timelines to 1–2 months compared with 6 months for standard priority review or 10 months for traditional review. Including this approval, these vouchers have led to 10 FDA approvals, four of them for novel drugs.3
Merck and the FDA both issued press releases on July 16th, the next day. Neither Merck's press release nor FDA's press release mention the CNPV program.4,5 It wasn’t until a second, separate FDA press release on Friday, July 17th, that the CNPV pilot gets a mention.6
It had been previously disclosed that Merck was submitting sections of the application to FDA, but there had been no public announcement that the application was ever accepted for filing.7 Even as recently as Merck's presentation at the 47th Annual Goldman Sachs Global Healthcare Conference on June 9th, the company indicated the submission process was still ongoing and had not been formally completed or accepted for filing.8
So the July 15th approval came as a surprise as there had been no announcement of filing acceptance. The approval letter states that the full submission was completed on June 22, 2026, which means that the approval on 15th July came only 23 days after the submission was complete.1
From the FDAs compilation of novel drug approvals which records all novel drug approvals since 1985, the fastest novel drug approval was for Orlaam (levomethadyl acetate hydrochloride), which was approved in just 18 days in 1993.9 Now this conflicts with this article's headline where I claim that this recent Lipfendra approval is the quickest novel drug approval. The 1993 18 day Orlaam approval follows a convoluted past where this represented the third NDA submission for this drug with the first two receiving CRLs, as a result I do not consider this 18 day timeline to be the true record holder.10 The next fastest novel drug approval was greater than 40 days.9
The 23-day record for Lipfendra is an extraordinarily quick approval for a novel drug, but is another point that has no mention in the company's press release or in the two FDA press releases. Odd for such a triumph of regulatory speed to go without a mention.
The CNPV pilot program was first developed last year by Commissioner Marty Makary who has since departed the FDA. The future status of the CNPV program remains uncertain but there are still 11 products that have vouchers which have not yet been redeemed. See the table below for an overview of all issued vouchers.
The full review documents have not yet been published in conjunction with the Lipfendra approval but I am keen on looking further into why this record approval speed and the review under the CNPV program seem to be under acknowledged.
References
1. U.S. Food and Drug Administration. FDA approval letter, NDA 220848 (Lipfendra/enlicitide). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220848Orig1s000ltr.pdf
2. U.S. Food and Drug Administration. FDA grants two national priority vouchers. https://www.fda.gov/news-events/press-announcements/fda-grants-two-national-priority-vouchers
3. U.S. Food and Drug Administration. Commissioner's National Priority Voucher (CNPV) pilot program. https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program
4. Merck & Co., Inc. Merck's LIPFENDRA® (enlicitide) is the first and only once-daily oral PCSK9 inhibitor approved by the U.S. FDA to reduce LDL-C in adults with hypercholesterolemia. https://www.merck.com/news/mercks-lipfendra-enlicitide-is-the-first-and-only-once-daily-oral-pcsk9-inhibitor-approved-by-the-u-s-fda-to-reduce-ldl-c-in-adults-with-hypercholesterolemia/
5. U.S. Food and Drug Administration. FDA approves first oral therapy that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) to lower bad cholesterol in adults with high cholesterol. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-therapy-inhibits-proprotein-convertase-subtilisinkexin-type-9-pcsk9-lower
6. U.S. Food and Drug Administration. FDA approves first oral PCSK9 inhibitor to lower LDL cholesterol in adults with high cholesterol. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol
7. Merck & Co., Inc. Merck Q1 2026 earnings call transcript. https://www.merck.com/wp-content/uploads/sites/124/2026/05/MRK-USQ_Transcript_2026-04-30.pdf
8. Merck & Co., Inc. Merck & Co., Inc. at Goldman Sachs Global Healthcare Conference. https://s21.q4cdn.com/488056881/files/doc_events/2026/Jun/09/MRK-USQ_Transcript_2026-06-09.pdf
9. U.S. Food and Drug Administration. Compilation of CDER new molecular entity (NME) drug and new biologic approvals. https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals
10. Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Market barriers to the development of pharmacotherapies for the treatment of cocaine abuse and addiction: Final report. https://aspe.hhs.gov/reports/market-barriers-development-pharmacotherapies-treatment-cocaine-abuse-addiction-final-report
