Merck Cholesterol, Cancer Drugs May Enter FDA Fast-Track Program: Report
The U.S. Food and Drug Administration (FDA) is preparing to fast-track reviews of two experimental Merck & Co. Inc. (NYSE:MRK) drugs with potential blockbuster sales.
Merck's cholesterol treatment enlicitide decanoate and cancer therapy sacituzumab tirumotecan (sac-TMT) have been reportedly selected for the FDA Commissioner's National Priority Voucher (CNPV) program, which accelerates regulatory decisions for medicines deemed critical to public health or national interests.
If finalized, the drugs would become the 17th and 18th to enter the program, according to internal documents reviewed by Reuters.
Also Read: Pallone, Sanders Warn FDA’s Fast-Track Vouchers Could Create Political Favoritism, Safety Risks
In September, Merck shared topline results from the Phase 3 CORALreef Lipids trial evaluating the safety and efficacy of enlicitide decanoate for hypercholesterolemia on a moderate or high intensity statin (or with documented statin intolerance).
The trial met all primary and key secondary endpoints. Treatment with enlicitide resulted in statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) compared to placebo at Week 24.
In June, the FDA announced its CNPV program. Drug developers may redeem the new voucher to participate in the FDA's novel priority program, which shortens the review time from approximately 10 to 12 months to one to two months following a sponsor’s final drug application submission.
The FDA expects Merck to submit its application for enlicitide in April and for sac-TMT in October or November next year.
The program has already been used for high-profile drugs, including Eli Lilly and Co.'s (NYSE:LLY) weight-loss pill, where FDA leadership pushed to further compress review timelines.
A compressed timeline could move Lilly’s target decision date to late March, well ahead of the current May 20 goal set by reviewers.
Several vouchers have been granted alongside agreements with the Trump administration to lower drug prices for government programs and cash-paying patients.
MRK Price Action: Merck stock is up 0.59% at $99.76 at publication on Thursday.
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