The FDA awarded six additional products a Commissioner’s National Priority Voucher, bringing the total number of recipients to 15, according to a Nov. 6 news release.
The pilot program aims to reduce drug review timelines to as short as two months for therapies addressing key public health priorities, affordability or domestic manufacturing, according to an Oct. 16 FDA podcast episode.
The agency named its first nine voucher recipients in October. Selected therapies were Cytisinicline for vaping cessation; DB-OTO, a gene therapy for congenital deafness; Teplizumab for Type 1 diabetes; a KRAS inhibitor for pancreatic cancer; Bitopertin for erythropoietic protoporphyria; ketamine and Augmentin for domestic manufacturing efforts; Pergoveris for infertility; and Cenegermin for vision loss.
The Nov. 6 announcement added six more:
- Zongertinib for HER2 lung cancer
- Bedaquiline for drug-resistant tuberculosis in young children
- Dostarlimab for rectal cancer
- Casgevy for sickle cell disease
- Orforglipron for obesity and related health conditions
- Wegovy for obesity and related health conditions
The FDA said voucher holders who submit complete applications can expect a decision within months.
