With the addition of the six new vouchers awarded today, the total number of CNPVs awarded is fifteen. It’s interesting to note that Dr. George Tidmarsh, the short-time CDER Director, was reported to have been critical of the CNPV program, worried that the compressed one to two month review and approval times would compromise safety and efficacy evaluations. But here we are with the second batch of vouchers out there waiting to be used.
The awardees of the six new vouchers are:
- Boehringer Ingelheim for Zongertinib, a drug used for HER2 lung cancer
- Johnson and Johnson for Bedaquiline for drug-resistant tuberculosis in young children
- GSK for Dostarlimab, a drug to treat rectal cancer
- Vertex and CRISPR Therapeutics for Casgevy, a treatment for sickle cell disease
- Eli Lilly for Orforglipron, a treatment for obesity and related health conditions
- Novo Nordisk for Wegovy for obesity and related health conditions
All but one of the drugs on this list (Orforglipron) have been approved previously for other indications.
We have blogged about the Commissioner’s priority review voucher program in the past here, here, here, and here. I, too, worry about the compressed timeframe for review and the potential for missing something important. Couple that with the longest government shutdown in history, during which the FDA cannot accept any new fee-paying applications, and you have the potential for a significant a backlog of submissions once the government reopens. The situation will likely create competition for resources for regular submissions and the priority voucher submissions will likely disadvantage some sponsors. Remember, if everything is first, nothing is first! Well, we’ll see how it goes and keep you informed.
