The FDA awarded two national priority review vouchers through its Commissioner’s National Priority Voucher pilot program on Dec. 19, bringing the total granted to 18.
The latest vouchers were issued for enlicitide decanoate, an oral PCSK9 inhibitor aimed at lowering LDL cholesterol, and sacituzumab tirumotecan, a trophoblast cell-surface antigen 2-directed antibody-drug conjugate. The program, launched in June, is designed to accelerate the review of therapies that address public health priorities or improve drug affordability and access.
Previous recipients include treatments for sickle cell disease, obesity, Type 1 diabetes, rectal cancer and drug-resistant tuberculosis. The FDA issued its first review decision under the program Dec. 9.
Voucher holders receive enhanced support throughout the review process, with applications targeted for decisions within one to two months.
