The U.S. Food and Drug Administration (FDA) is considering awarding Commissioner’s National Priority Vouchers to two investigational drugs from Merck, according to a report from Reuters published Wednesday. The drugs in question—enlicitide decanoate, a cholesterol-lowering pill, and sacituzumab tirumotecan, an antibody-drug conjugate for cancer—are both seen as having blockbuster potential.
Reuters reported that internal FDA documents indicate both medicines are being considered for the priority voucher program. These vouchers would allow for a much shorter regulatory review period if granted.
Merck has not yet submitted approval applications for either drug. However, the FDA reportedly expects an application for enlicitide decanoate in April and one for sacituzumab tirumotecan in November of next year.
A spokesperson for the Department of Health and Human Services told Reuters: "Absent any official announcement from the FDA, reports regarding CNPV awards will remain speculative in nature."
Enlicitide decanoate is designed to block the PCSK9 enzyme and reduce low-density lipoprotein cholesterol (LDL-C). At the American Heart Association’s 2025 Scientific Sessions last month, trial data showed that patients taking enlicitide decanoate had LDL-C levels lowered by 55.8% compared to placebo at 24 weeks. Following earlier Phase III results announced in June, BMO Capital Markets analysts said the drug could be a “multi-billion dollar opportunity.”
Sacituzumab tirumotecan is being developed for several oncology indications including non-small cell lung cancer. Results from the Phase III OPtiTROP-Lung04 study published in October in the New England Journal of Medicine indicated that it reduced risk of disease progression or death by 51% compared with chemotherapy. The drug is also under investigation for other cancers such as breast, cervical, gastric, biliary tract, colorectal and pancreatic cancers.
In November, Merck entered into a $700 million funding agreement with Blackstone Life Sciences to support development of sacituzumab tirumotecan. Jefferies analysts told Reuters that this deal suggests sales of the molecule could reach $10 billion.
The Commissioner’s National Priority Voucher program was introduced by the FDA in June to speed up approval processes for drugs addressing federal priorities like lowering medication costs and enhancing domestic manufacturing. Under this program, review periods can be shortened from 10–12 months to just 1–2 months.
Since its launch, priority vouchers have been given to 16 different molecules—including Novo Nordisk’s Wegovy weight-loss treatment, Eli Lilly’s oral obesity candidate orforglipron and USAntibiotics’ Augmetin XR antibiotic formulation. Augmentin XR received approval earlier this month. Most recently, Johnson & Johnson was awarded a voucher without applying for it.
