Fidanacogene elaparvovec information

Fidanacogene elaparvovec
Gene therapy
Vector	Adeno-associated virus
Clinical data
Trade names	Beqvez
Other names	SPK-9001
Biosimilars	fidanacogene elaparvovec-dzkt
License data	US DailyMed: Fidanacogene elaparvovec;
Routes of; administration	Intravenous
ATC code	None;
Legal status
Legal status	CA: ℞-only / Schedule D; US: ℞-only;
Identifiers
CAS Number	1954659-47-2;
DrugBank	DB16783;
UNII	413EU9081Y;

Fidanacogene elaparvovec, sold under the brand name Beqvez, is a gene therapy delivered via adeno-associated virus used for the treatment of Hemophilia B (congenital Factor IX deficiency).^[1]^[5]^[7]

It was approved for medical use in Canada in December 2023,^[1] and in the United States in April 2024.^[6]^[8]

^ ^a ^b ^c "Beqvez Product information". Health Canada. 22 October 2009. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28]". Health Canada. 28 February 2024. Archived from the original on 2 March 2024. Retrieved 2 March 2024.
^ "Details for: Beqvez". Health Canada. 27 December 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
^ "Regulatory Decision Summary for Beqvez". Drug and Health Products Portal. 27 December 2023. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
^ ^a ^b "Archived copy". Archived from the original on 29 April 2024. Retrieved 29 April 2024.{{cite web}}: CS1 maint: archived copy as title (link)
^ ^a ^b "Beqvez". U.S. Food and Drug Administration (FDA). 25 April 2024. STN: 125786. Archived from the original on 29 April 2024. Retrieved 29 April 2024. This article incorporates text from this source, which is in the public domain.
^ "fidanacogene elaparvovec". CADTH. 20 June 2023. Archived from the original on 2 March 2024. Retrieved 2 March 2024.
^ "U.S. FDA Approves Pfizer's Beqvez (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B" (Press release). Pfizer. 26 April 2024. Archived from the original on 29 April 2024. Retrieved 29 April 2024 – via Business Wire.

[Beqvez_PI_CA-1] "Beqvez Product information". Health Canada. 22 October 2009. Archived from the original on 3 March 2024. Retrieved 3 March 2024.

[CA_PDL_additions-2] "Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28]". Health Canada. 28 February 2024. Archived from the original on 2 March 2024. Retrieved 2 March 2024.

[3] "Details for: Beqvez". Health Canada. 27 December 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.

[4] "Regulatory Decision Summary for Beqvez". Drug and Health Products Portal. 27 December 2023. Archived from the original on 2 April 2024. Retrieved 2 April 2024.

[Beqvez_FDA_label-5] "Archived copy". Archived from the original on 29 April 2024. Retrieved 29 April 2024.{{cite web}}: CS1 maint: archived copy as title (link)

[FDA_Beqvez-6] "Beqvez". U.S. Food and Drug Administration (FDA). 25 April 2024. STN: 125786. Archived from the original on 29 April 2024. Retrieved 29 April 2024. This article incorporates text from this source, which is in the public domain.

[7] "fidanacogene elaparvovec". CADTH. 20 June 2023. Archived from the original on 2 March 2024. Retrieved 2 March 2024.

[8] "U.S. FDA Approves Pfizer's Beqvez (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B" (Press release). Pfizer. 26 April 2024. Archived from the original on 29 April 2024. Retrieved 29 April 2024 – via Business Wire.