Wedoany.com Report-Dec.18, The U.S. Food and Drug Administration plans to accelerate reviews for two experimental Merck drugs with substantial commercial prospects.

Merck's cholesterol treatment enlicitide decanoate and its cancer therapy sacituzumab tirumotecan (sac-TMT) have been selected for the Commissioner's National Priority Voucher program. These would become the 17th and 18th medicines in the initiative.

The FDA anticipates Merck's submission for enlicitide in April and for sac-TMT in October or November of the following year.

Introduced in June, the voucher program shortens review periods to one or two months for drugs addressing significant public health or national security needs, compared to the standard 10 to 12 months.

A spokesperson for the Department of Health and Human Services, which supervises the FDA, noted that until an official announcement, details remain speculative. The spokesperson added that the program "strengthens FDA’s ability to accelerate development of products that meet urgent public health needs."

Merck declined to comment.

In clinical trials, enlicitide demonstrated notable reductions in LDL cholesterol levels compared to placebo in patients with hypercholesterolemia, a condition associated with elevated cardiovascular risks. Merck has positioned enlicitide as a potential first oral PCSK9 inhibitor, projecting multibillion-dollar peak annual sales. It would compete with existing injectable options such as Amgen's Repatha.

Sac-TMT, an antibody-drug conjugate designed to target cancer cells more precisely while sparing healthy tissue, is under evaluation for various tumor types, including breast, endometrial, and lung cancers. Analysts at Jefferies estimate potential peak annual sales exceeding $10 billion. Merck recently secured a $700 million funding agreement with Blackstone Life Sciences to support its development.

These advancements form part of Merck's efforts to strengthen its pipeline ahead of increased competition for its leading cancer therapy Keytruda from biosimilar products later this decade.

The FDA recently granted its 16th National Priority Review voucher to Johnson & Johnson for a combination treatment involving Tecvayli and Darzalex in blood cancer.

Priority designations under this program have been extended to select candidates, including some linked to pricing arrangements for prescription medicines in government and direct-pay contexts.

The accelerated pathway enables quicker access to promising therapies while maintaining rigorous evaluation standards. For Merck, inclusion in the program could expedite availability of treatments addressing prevalent conditions in cardiovascular health and oncology.

Ongoing development of these drugs reflects continued investment in innovative pharmaceuticals aimed at improving patient outcomes in high-need areas. Stakeholders monitor submission timelines and review progress for updates on potential approvals.