Fidanacogene elaparvovec is a gene therapy designed to introduce in the transduced cells a functional copy of the factor IX gene encoding a high-activity FIX variant (FIX-R338L, hFIX Padua). The AAVRh74var capsid is able to transduce hepatocytes, the natural site of factor IX synthesis. Single intravenous infusion of fidanacogene elaparvovec results in cell transduction and increase in circulating factor IX activity in patients with hemophilia B.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| B02BD17 | B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors | |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| BEQVEZ Solution for infusion | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
Fidanacogene elaparvovec is an active ingredient of these brands:
United States (US)Austria (AT)Canada (CA)Lithuania (LT)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
