'U.S. FDA Moving To Fast-Track Reviews Of Two Merck Drugs Under Commissioner National Priority Voucher Pilot Program; Merck's Cholesterol Pill Enlicitide And Cancer Therapy Sac-TMT Tapped For Program; FDA Expects Respective April And October/ November Submission Dates For Enlicitide And Sac-TMT, Internal Documents Say' - Reuters Exclusive

• Merck cholesterol pill enlicitide and cancer therapy sac-TMT tapped for new priority program
• FDA expects Merck to submit applications in April and autumn of 2026, documents show
• Both drugs if approved are expected to generate multibillion-dollar sales

Dec 17 (Reuters) - The U.S. Food and Drug Administration is moving to fast-track reviews of two experimental Merck MRK.N drugs with multibillion-dollar potential, according to internal documents seen by Reuters.

Merck's cholesterol pill enlicitide decanoate and its cancer therapy sacituzumab tirumotecan, or sac-TMT, have been tapped for the Commissioner's National Priority Voucher program, potentially making them the 17th and 18th medicines included in the new program, documents show.

The FDA expects Merck to submit its applications for enlicitide in April and for sac-TMT in October or November next year, according to one document.

Launched in June, the voucher program aims to speed FDA decisions for drugs with critical public health or national security impact, promising one- to two-month reviews versus the usual 10 to 12 months.

For Eli Lilly's LLY.N weight-loss pill evaluation, reviewers set a six-month total timeline under the program, which FDA leaders were pushing to cut by up to seven weeks.

Several priority review vouchers, including Lilly's, were awarded as part of deals with the Trump administration to lower the prices of prescription medicines for government programs and cash-paying patients. Other drug candidates were invited to participate.

A spokesperson for the Department of Health and Human Services, which oversees the FDA, said until there is an official announcement from the agency, this report is speculation. It said, however, the voucher program "strengthens FDA's ability to accelerate development of products that meet urgent public health needs."

Merck declined to comment.