2022 biological license application approvals fda hemgenix?

What FDA approvals in 2022 covered Hemgenix (etranacogene dezaparvovec-drlb)?

Hemgenix is a gene therapy for hemophilia B. In 2022, the FDA approval that applies to Hemgenix is its biologics license approval for clinical use in the United States. The FDA’s approval is reflected in the Biologics License Application (BLA) approval records for 2022 [1].

Which BLA number and indication did FDA approve for Hemgenix in 2022?

Hemgenix’s approval was filed as a BLA and approved for the treatment of people with hemophilia B who have factor IX levels that are below a specified threshold (as described in FDA’s approval/labeling materials for Hemgenix) [1].

Is Hemgenix the only hemophilia B gene therapy BLA approved in 2022?

FDA approved multiple hemophilia-related products and gene-therapy products around this period, but Hemgenix’s specific 2022 approval refers to its own BLA approval entry in FDA’s biologics approval records for that year [1].

Where can I verify the exact 2022 FDA approval entry for Hemgenix?

You can verify the specific 2022 approval entry (including the approval date and reference details) in FDA’s BLA approval records for 2022 listed under Hemgenix [1].

Sources

1. https://www.fda.gov/vaccines-blood-biologics/biologics-licensing-application-bla/approved-bla-2013-present