United States — The U.S. Food and Drug Administration (FDA) has awarded Commissioner’s National Priority Review Vouchers to two investigational therapies developed by Merck & Co., Inc., highlighting the agency’s intent to accelerate review of treatments addressing significant public health needs.
The vouchers were granted under the FDA’s National Priority Voucher pilot program, which provides enhanced regulatory engagement and enables the FDA to complete application reviews within a significantly shortened timeframe—often within one to two months, compared with standard review timelines.
The two Merck therapies receiving the designation include:
- Enlicitide decanoate, an oral PCSK9 inhibitor intended for the treatment of high low-density lipoprotein (LDL) cholesterol. The therapy represents a potential alternative to injectable cholesterol-lowering agents and is being evaluated for its ability to meaningfully reduce LDL levels in patients with hypercholesterolemia.
- Sacituzumab tirumotecan (sac-TMT), an antibody-drug conjugate (ADC) designed for oncology indications. The therapy is engineered to deliver targeted anti-cancer agents directly to tumor cells while limiting exposure to healthy tissue.
These latest awards bring the total number of vouchers issued under the FDA’s priority initiative to eighteen since the program’s launch earlier this year. The program is designed to focus regulatory resources on therapies that address serious diseases, large patient populations, or unmet medical needs.
Merck reported that both therapies are supported by advancing clinical data. Enlicitide has demonstrated promising cholesterol-lowering effects in late-stage trials, while sac-TMT continues to be studied across multiple cancer indications.
The company stated that it will work closely with the FDA as development progresses and emphasized its commitment to advancing innovative medicines in cardiometabolic disease and oncology.
About the FDA National Priority Review Voucher Program
The Commissioner’s National Priority Review Voucher program is a pilot initiative aimed at accelerating regulatory review for drugs and biologics that have the potential to deliver meaningful public health impact.
About Merck & Co., Inc.
Merck & Co., Inc. is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines and vaccines across oncology, cardiometabolic disease, infectious diseases, and immunology.
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