FDA Grants CNPV Priority Review Vouchers to Six New Drug Applications, Accelerating Approval to 1-2 Months

On November 6th, U.S. time, the FDA announced the list of recipients for the second batch of Country Priority Review Vouchers (CNPV).All the drugs that received vouchers this time, except for orforglipron from Eli Lilly, are already marketed drugs.

CNPV was first launched in June this year to support projects that align with the "U.S. National Priorities," covering multiple categories, including addressing public health crises in China, tackling unmet medical needs, localizing pharmaceutical R&D and manufacturing, or improving drug accessibility.With this voucher, the drug review process can be shortened from 10-12 months to 1-2 months.

This round obtainedPriority Review VoucherThe products include:

• Boehringer Ingelheim's Zongertinib, for the treatment of HER2 lung cancer
• Johnson & Johnson's bedaquiline, for drug-resistant tuberculosis in young children
• GSK China's dostarlimab, for rectal cancer
• Vertex and CRISPR Therapeutics' Casgevy, for Sickle Cell Disease

• Eli Lilly's orforglipron, for obesity and related health conditions

• Novo Nordisk's Wegovy, for obesity and related health conditions

The latest batch of CNPV recipients are mainly concentrated in large companies and their drugs that have been approved for at least one indication.This is different from the first batch of CNPV recipients announced on October 17, which represented nine companies of various sizes in the pharmaceutical industry as well as different stages of the drug development pipeline.