Merck's Oral PCSK9 Inhibitor Enlicitide (MK-0616) NDA Accepted by China CDE

Zhitong Finance APP learned that on July 9, the CDE official website showed that Merck & Co. (MRK.US)'s Class 1 new drug "Enlicitide Tablets" marketing application has been accepted. Merck previously stated in a press release that Enlicitide is expected to become the first approved oral PCSK9 inhibitor.

Source: CDE Official Website

Enlicitide tablets (Enlicitide, development code: MK-0616) are an oral macrocyclic peptide PCSK9 inhibitor developed by Merck & Co., designed to provide LDL-C lowering effects comparable to those of PCSK9 monoclonal antibodies while maintaining a safety profile similar to that of placebo. The efficacy and safety of enlicitide are being evaluated through the comprehensive CORALreef clinical trial program, which includes CORALreef Outcomes, CORALreef HeFH, CORALreef Lipids, and CORALreef Add-On.

Insight database shows that currently 7 PCSK9-targeted drugs have been approved in China, including evolocumab, alirocumab, inclisiran sodium, toludesmab, inusitumab, ongericimab, and recaticimab. Among them, inclisiran sodium differs from the other six as it is a small interfering RNA (siRNA) drug with more convenient administration; after the first two doses, it can be administered once every six months. In addition, Salubris’ ticasimab, Everest Medicines’ ledacibep, and Merck’s enlicitide are all under marketing application review.