Merck Scores FDA Fast-Track Review For Key Cholesterol And Cancer Drugs With Multibillion-Dollar Potential: Report

While one of the drugs reportedly slated for fast-track review is the cholesterol pill Enlicitide Decanoate, the other is Merck's cancer therapy Sacituzumab Tirumotecan.

• As per Reuters, both the drugs have multibillion-dollar potential.
• FDA expects Merck to submit its applications for Enlicitide in April and for Sac-TMT in October or November next year.
• Other drugs chosen for fast-track review include Achieve Life Sciences’ Cytisinicline for nicotine vaping addiction and Lilly’s weight loss drug Orforglipron.

The U.S. Food and Drug Administration is reportedly preparing to fast-track reviews of two experimental Merck drugs with high patient demand.

Reuters reported on Wednesday, citing internal documents, that both the experimental drugs have multibillion-dollar potential. While one of the drugs slated for fast-track review is the company’s cholesterol pill Enlicitide Decanoate, the other is its cancer therapy Sacituzumab Tirumotecan.

Both the drugs have been tapped for the Commissioner's National Priority Voucher program aimed at accelerated reviews and will be the 17th and 18th medicines to be eligible for fast-track review under the program, the report said.

The agency expects Merck to submit its applications for Enlicitide in April and for sac-TMT in October or November next year.

The Voucher Program

The Commissioner's National Priority Voucher program, announced in June, aims to reduce FDA assessment times to one to two months from the standard 10 to 12 months. Several drugs have been awarded the voucher including Merck Group’s infertility treatment Pergoveris, Sanofi’s Type 1 diabetes therapy Teplizumab, and Regeneron’s gene therapy DB-OTO for congenital deafness.

Revolution Medicines’ RMC-6236 for pancreatic cancer, Disc Medicine’s Bitopertin for porphyria, Achieve Life Sciences’ Cytisinicline for nicotine vaping addiction, and Lilly’s weight loss drug Orforglipron are also part of the program.

Merck’s Drug Updates

In September, Merck said that treatment with Enlicitide resulted in a statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol compared to placebo at week 24 in a late-stage trial in patients with hypercholesterolemia, a disorder characterized by elevated LDL cholesterol levels in the blood. The investigational drug also reduced non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein, the firm said.

As for Sacituzumab Tirumotecan or Sac-TMT, Merck announced last month that it has inked a deal under which Blackstone Life Sciences will pay Merck $700 million to fund a portion of its development costs. Merck is currently evaluating the drug in multiple global late-stage trials spanning six tumor types, including breast, endometrial, and lung cancers. The funding agreement will help fund a portion of the development costs in 2026, it said.

Merck is currently attempting to advance its pipeline as its blockbuster drug Keytruda closes in on patent expiry, raising the risk of competition from biosimilars. The drug brought in $29.5 billion in sales in fiscal year 2024, marking a growth of 18%, and accounting for a significant chunk of the company's overall $64.2 billion sales.

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