The FDA is gearing up to accelerate reviews of two experimental drugs from Merck & Co. Inc. (MRK) that could deliver blockbuster sales, according to internal documents reviewed by Reuters.

Both enlicitide decanoate, a cholesterol treatment, and sacituzumab tirumotecan (sac-TMT), a cancer therapy, have reportedly been selected for the FDA Commissioner's National Priority Voucher (CNPV) program. This initiative fast-tracks regulatory decisions for medicines considered critical to public health or national interests.

If these selections are finalized, the drugs would become the 17th and 18th medications to enter the program, which launched just last June.

What Makes These Drugs Special?

Start with the cholesterol treatment. In September, Merck released topline results from its Phase 3 CORALreef Lipids trial evaluating enlicitide decanoate for hypercholesterolemia patients on moderate or high-intensity statins, or those with documented statin intolerance.

The results were promising. The trial hit all primary and key secondary endpoints, with enlicitide delivering statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to placebo at Week 24.

How Fast is Fast-Track?

Here's where things get interesting. The CNPV program can shrink FDA review times from the typical 10 to 12 months down to a remarkably brisk one to two months following a sponsor's final drug application submission. That's the kind of timeline compression that gets drugmakers excited.

The FDA expects Merck to submit its application for enlicitide in April, with the sac-TMT cancer therapy application following in October or November of next year.

The Program's Track Record

The priority voucher program has already been deployed for some high-profile medications, including Eli Lilly and Co.'s (LLY) weight-loss pill. In that case, FDA leadership pushed to compress review timelines even further.

A compressed timeline could shift Lilly's target decision date to late March, well ahead of the current May 20 goal set by reviewers. That's the kind of acceleration that can reshape market expectations and competitive landscapes.

Worth noting: several vouchers have been granted alongside agreements with the Trump administration to lower drug prices for government programs and cash-paying patients. The message seems to be that expedited reviews come with expectations around pricing commitments.

MRK Price Action: Merck stock is up 0.59% at $99.76 at publication on Thursday.