BRIEF—FDA grants two national priority vouchers

The US Food and Drug Administration (FDA) on Friday awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase access through affordability for American patients.

The products are: enlicitide decanoate - an oral PCSK9 inhibitor for lowering LDL cholesterol under development by Merck & Co (NYSE: MRK); and sacituzumab tirumotecan- a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate, also being developed by Merck.

“High health care costs and prescription drug prices threaten to undermine all the technological advancements we see in the medical field,” said FDA Commissioner Dr Marty Makary, adding: “We’re pleased to grant these vouchers to two products that may significantly contribute to our goal of improving the accessibility and affordability of healthcare in America.”