💊FDA Approves EYLEA HD with Priority Review Voucher
Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept)
Summary
The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat medical countermeasure (MCM) product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for EYLEA HD (aflibercept), approved August 18, 2023, meets the criteria for redeeming a priority review voucher.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's approval of EYLEA HD under a priority review voucher indicates potential financial incentives for businesses involved in medical countermeasures and drug development. The notice outlines that approved products can access expedited review pathways, which can influence market positioning and investment opportunities in the pharmaceutical sector.