FDA Fast-Tracks Two New Merck Drugs with Billion-Dollar Potential

The FDA is expediting the review of Merck's experimental drugs, enlicitide decanoate and sacituzumab tirumotecan. These drugs are part of a new priority voucher program aiming to shorten review times from 10-12 months to one or two months for drugs of significant public health impact.

The U.S. Food and Drug Administration (FDA) is set to fast-track the reviews of two Merck drugs, each with the potential for blockbuster sales, according to internal documents acquired by Reuters. These drugs, enlicitide decanoate and sacituzumab tirumotecan, have been selected for the FDA's Commissioner's National Priority Voucher program, potentially accelerating their approval process from the usual 10-12 months down to one or two months.

Enlicitide decanoate, a cholesterol-lowering pill, showed promise in a recent trial where it significantly reduced LDL cholesterol levels in hypercholesterolemia patients. Expected to launch shortly, it could become the first oral PCSK9 inhibitor on the market, giving it a competitive edge over injectable alternatives like Amgen's Repatha. The second drug, sac-TMT, recently benefited from a $700 million funding deal with Blackstone Life Sciences, and is being tested against various cancers.

While the FDA's latest National Priority Review voucher benefitted Johnson & Johnson's cancer treatment, the inclusion of Merck's drugs awaits official confirmation. The priority voucher program aims to hasten the development of pharmaceuticals addressing urgent public health needs, supported by recent government initiatives focusing on drug pricing.

(With inputs from agencies.)