Dompé announced its selection by the US Food and Drug Administration (FDA) to participate in the Commissioner’s National Priority Voucher (CNPV) program.

According to the FDA, the CNPV pilot program offers an opportunity to reduce drug and biological product application or efficacy supplement review times from 10-12 months to just 1-2 months. This program uses a collaborative tumor board style review process to accelerate approvals for companies aligned with critical US national health priorities.

Because of its selection, Dompé has been awarded a voucher granting it a significantly shortened review timeline for marketing application and enhanced collaboration with the FDA. 

The company relays in a press release that it intends to apply the voucher for the Biologic License Application (BLA) for an intranasally administered formulation of nerve growth factor (NGF) (Cenegermin-bkbj) for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION).

Specifically, Dompe says it has planned a registrational pivotal trial program in more than 130 sites across 16 countries. OM