SHERIDAN, WYOMING - December 19, 2025 - The FDA is considering awarding Commissioner's National Priority Vouchers to two investigational Merck programs-PCSK9 pill enlicitide decanoate and antibody-drug conjugate sacituzumab tirumotecan-an early signal that the agency may be willing to accelerate reviews for high-impact products even before formal filings, according to a Reuters report.
A new FDA lever that can reshape launch timing
Commissioner's National Priority Vouchers are designed to shorten the FDA's regulatory review window from the typical 10-12 months to 1-2 months. For large pharma, that time compression can meaningfully shift competitive dynamics-pulling forward commercialization, altering payer and guideline sequencing, and increasing the urgency of manufacturing readiness, launch supply, and field execution.
The program launched in June and has already been applied to a range of high-profile products. Since rollout, the FDA has issued vouchers to 16 molecules, including Novo Nordisk's Wegovy, Eli Lilly's oral obesity candidate orforglipron, and USAntibiotics' amoxicillin formulation Augmetin XR, which was approved earlier this month. Most recently, Johnson & Johnson received a voucher earlier this week, reportedly without even applying for it.
HHS response underscores uncertainty until FDA acts
Despite the reported internal deliberations, a spokesperson for the Department of Health and Human Services cautioned against over-reading the situation. In a statement to Reuters, the spokesperson said that absent any official announcement from the FDA, reports regarding CNPV awards will remain "speculative in nature."
For investors and partners, that language matters: a voucher changes speed, not outcome, and cannot substitute for submission quality, clinical benefit-risk, CMC completeness, and inspection readiness.
Enlicitide decanoate: oral PCSK9 inhibition with blockbuster expectations
Merck's enlicitide decanoate is positioned as an orally available blocker of the PCSK9 enzyme intended to reduce low-density lipoprotein cholesterol (LDL-C). At the American Heart Association's 2025 Scientific Sessions, the drug cut LDL-C by 55.8% versus placebo at 24 weeks, supporting its late-stage profile in a market where convenience and adherence are central commercial drivers.
Reuters reported that Merck has not yet filed an approval application, but the FDA expects a submission for enlicitide decanoate in April of next year. Following Phase III results announced in June, BMO Capital Markets analysts described the program as a "multi-billion dollar opportunity." If a voucher were ultimately granted, it could compress the time between submission and label decision-raising the stakes for launch logistics, payer contracting, and real-world evidence plans.
Sacituzumab tirumotecan: an ADC portfolio play across multiple tumors
Sacituzumab tirumotecan is being developed across oncology indications, including non-small cell lung cancer, with additional trials in breast, cervical, gastric, biliary tract, colorectal, and pancreatic cancers. Reuters cited Phase III data from OPtiTROP-Lung04 published in October in the New England Journal of Medicine showing the ADC reduced the risk of disease progression or death by 51% versus chemotherapy.
Merck is expected to submit sacituzumab tirumotecan in November of next year, according to Reuters. The company also signed a $700 million funding agreement with Blackstone Life Sciences in November to advance development, with Jefferies analysts indicating the molecule could reach $10 billion in sales, per Reuters-placing it among the most commercially consequential late-stage assets competing in the crowded ADC landscape.
Strategic implications: faster reviews raise execution demands
If Merck were to receive vouchers for either asset, accelerated review would increase cross-functional pressure on regulatory, quality, and manufacturing teams to ensure "submission-to-launch" readiness. For healthcare systems and payers, the same acceleration can compress evaluation windows-making pre-submission engagement, evidence packages, and access planning more critical.
For full context on Merck's late-stage development priorities, visit https://www.merck.com/research/product-pipeline/.