The tickets could go to the lipid-lowering pill enlicitide decanoate and the antibody-drug conjugate sacituzumab tirumotecan, though a spokesperson for the HHS did not confirm the news.
The FDA is considering giving Commissioner’s National Priority Vouchers to two investigational drugs from Merck, both with blockbuster potential, according to a Wednesday report from Reuters.
After reviewing internal FDA documents, Reuters revealed that the cholesterol-lowering pill enlicitide decanoate and the antibody-drug conjugate (ADC) sacituzumab tirumotecan are each in the running for a priority voucher, which, if granted, would drastically reduce their respective review periods.
Merck has yet to file an approval application for either of these molecules but the FDA expects a submission for enlicitide decanoate in April and sacituzumab tirumotecan in November of next year, according to Reuters.
In a statement to Reuters, a spokesperson for the Department of Health and Human Services said that absent any official announcement from the FDA, reports regarding CNPV awards will remain speculative in nature.
Enlicitide decanoate is an orally available blocker of the PCSK9 enzyme, working to reduce levels of low-density lipoprotein cholesterol (LDL-C). At the American Heart Association’s 2025 Scientific Sessions last month, the drug cut LDL-C concentrations by 55.8% versus placebo at 24 weeks.
After Merck announced data showing enlicitide decanoate lowered cholesterol levels in two Phase III trials in June, BMO Capital Markets analysts wrote in a note to investors that the drug represented a “multi-billion dollar opportunity.”
Meanwhile, Merck is developing sacituzumab tirumotecan for various oncology indications, including non-small cell lung cancer. Data from the Phase III OPtiTROP-Lung04 study, published in October in the New England Journal of Medicine, showed the ADC cut the risk of disease progression or death by 51% versus chemotherapy.
Merck is also testing sacituzumab tirumotecan for breast, cervical, gastric, biliary tract, colorectal and pancreatic cancers.
In November, Merck signed a $700 million funding agreement with Blackstone Life Sciences to develop the ADC. Jefferies analysts noted that the Blackstone deal indicated the molecule could reach $10 billion in sales, according to Reuters.
The FDA rolled out the Commissioner’s National Priority Voucher program in June, looking to accelerate the approval process for drugs that satisfy certain federal priorities, such as lowering drug prices and boosting domestic manufacturing. These tickets shorten the regulatory review period from the usual 10–12 months to 1–2 months.
Since the program’s launch, the FDA has handed out priority vouchers to 16 molecules, including Novo Nordisk’s weight-loss blockbuster Wegovy, Eli Lilly’s oral obesity candidate orforglipron and USAntibiotics’ antibiotic amoxicillin formulation Augmetin XR. Augmentin XR was approved earlier this month. Most recently, Johnson & Johnson earlier this week was granted a voucher—without even applying for it.
