Two investigational products have received national priority vouchers from the FDA due to their potential to increase access through affordability for patients in the U.S.
The first product is Merck's enlicitide decanoate, which has the potential to be the first approved oral PCSK9 inhibitor to lower LDL-C with a safety profile comparable to placebo. Enlicitide may help address unmet needs in ASCVD, a key driver of the ongoing cardiovascular epidemic.
The second is sacituzumab tirumotecan, a trophoblast cell-surface antigen 2 (TROP2)-directed antibody conjugate for advanced cancers. Merck is developing the ADC in collaboration with Kelun-Biotech.
The products received the vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program, which shortens drug review times for companies “aligned with U.S. national priorities.” Review times are reduced to one or two months, down from around 10 to 12 months, following a sponsor’s final drug application submission. The number of products that have received such a voucher now totals 18.
Last week, the FDA approved USAntibiotics' Augmentin XR through the CNPV pilot program, making the antibiotic the first drug to receive approval using this review pathway. Augmentin XR is an oral antibacterial combination of amoxicillin (a semisynthetic antibiotic) and clavulanate (a β-lactamase inhibitor). The medication is prescribed for community-acquired pneumonia and acute bacterial sinusitis. The drug received approval after just two months.