Merck Cholesterol, Cancer Drugs May Enter FDA Fast-Track Program: Report

Core Insights - The FDA is set to fast-track reviews for two Merck drugs, enlicitide decanoate and sacituzumab tirumotecan, under the CNPV program, which aims to expedite regulatory decisions for critical medicines [1][5] - If approved, these drugs will be the 17th and 18th to enter the CNPV program, highlighting their potential significance in the market [2] - Merck's enlicitide decanoate has shown promising results in the Phase 3 CORALreef Lipids trial, achieving significant reductions in LDL-C compared to placebo [4] Group 1 - The FDA's CNPV program was announced in June, allowing for a significant reduction in review time from approximately 10-12 months to 1-2 months post-application submission [5] - Merck plans to submit its application for enlicitide in April and for sac-TMT in October or November of the following year [5] - The CNPV program has previously been utilized for notable drugs, including Eli Lilly's weight-loss pill, indicating its importance in the pharmaceutical landscape [6] Group 2 - Merck's stock price increased by 0.59% to $99.76 at the time of publication, reflecting positive market sentiment regarding the potential approval of these drugs [7]