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FDA Eyes Fast-Track for Merck's Blockbuster Drugs
18 Dec, 2025
Summary
- Two experimental Merck drugs, enlicitide and sac-TMT, may get fast-tracked.
- The drugs target cholesterol and cancer with significant sales potential.
- FDA's priority program aims for faster reviews of critical medicines.
The U.S. Food and Drug Administration is reportedly fast-tracking reviews for two promising experimental Merck drugs, enlicitide and sacituzumab tirumotecan (sac-TMT). These medications, with projected multibillion-dollar sales, have been identified for inclusion in the Commissioner's National Priority Voucher program. This initiative is designed to expedite FDA decisions for drugs deemed critical for public health and national security.
Merck anticipates submitting applications for enlicitide, a potential first-in-class oral PCSK9 inhibitor for hypercholesterolemia, in April of next year. The cancer therapy sac-TMT is expected to follow in October or November. The voucher program allows for expedited, one- to two-month reviews, a substantial reduction from the usual 10- to 12-month timeframe.
