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# Merck Cholesterol, Cancer Drugs Added to Voucher Program
- URL: https://www.fdaweb.com/merck-cholesterol-cancer-drugs-added-to-voucher-program/
- Published: 2025-12-17T12:00:00.000Z
- Updated: 2026-09-14T15:29:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160407

FDA has chosen two investigational drugs from Merck for expedited regulatory reviews under its Commissioner's National Priority Voucher program, according to internal agency documents reviewed by Reuters. The drugs — a cholesterol treatment and an oncology therapy — could become the 17th and 18th products included in the fast-track initiative, which was launched earlier this year to accelerate approvals for medicines deemed critical to public health or national security.

The cholesterol drug, enlicitide decanoate, and the cancer therapy sacituzumab tirumotecan, also known as sac-TMT, are both viewed by analysts as having multibillion-dollar sales potential. FDA documents indicate the agency expects Merck to submit an application for enlicitide in April, followed by an application for sac-TMT in October or November, according to Reuters.

The voucher program, announced in June, aims to compress FDA review timelines to one or two months, compared with the standard 10- to 12-month review process. In at least one case — the review of a weight-loss pill from Eli Lilly — FDA leadership has pushed reviewers to shorten a six-month timeline by several additional weeks ([see earlier story](https://www.fdaweb.com/fda-gives-expedited-review-for-lilly-obesity-pill/)).

Merck has positioned enlicitide as a potential first-in-class oral PCSK9 inhibitor for patients with hypercholesterolemia, a condition marked by dangerously high levels of LDL cholesterol and increased risk of heart attack and stroke, according to Reuters. In a late-stage, 24-week trial, the drug significantly reduced LDL cholesterol levels compared with placebo, the company reported in September.

At a major medical conference last month, Merck said it expects enlicitide to achieve multibillion-dollar peak annual sales. If approved, the drug would compete with injectable PCSK9 therapies such as Repatha from Amgen.

Meanwhile, Sac-TMT is an antibody-drug conjugate designed to deliver chemotherapy more precisely to cancer cells, reducing damage to healthy tissue. Merck has been testing the drug across multiple tumor types, including breast, endometrial, and lung cancers. Analysts at Jefferies suggested potential peak annual sales could exceed $10 billion, Reuters says.

The fast-tracking of both drugs comes as Merck works to replenish its pipeline ahead of looming competition for its flagship cancer therapy Keytruda, which generates nearly $30 billion in annual revenue and is expected to face biosimilar competition later this decade.