FDA Eyes Fast-Track for Merck's Blockbuster Drugs

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.

Enlicitide has demonstrated significant LDL cholesterol reduction in trials, while sac-TMT, an antibody-drug conjugate, targets various cancers. Both drugs represent significant advancements in their respective fields, with analysts projecting peak annual sales potentially exceeding $10 billion for sac-TMT alone. These developments are crucial for Merck as it aims to expand its pipeline ahead of future competition for its blockbuster drug Keytruda.