Casgevy (exagamglogene Autotemcel (exa-cel))

BL 125787 / BL 125785

Casgevy (exagamglogene Autotemcel (exa-cel))

BL 125787 / BL 125785

U.S. License Holder:

Vertex Pharmaceuticals Inc.

Date of License:

December-08-2023

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

BL 125787: CASGEVY (exagamglogene Autotemcel (exa-cel)) is an autologous genome edited hematopoietic stem cell-based gene therapy indicated for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises (VOCs)

BL 125785: CASGEVY (exagamglogene Autotemcel (exa-cel)) is an autologous genome edited hematopoietic stem cell-based gene therapy indicated for the treatment of patients aged 12 years and older with:

Sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs);

Transfusion-dependent beta-thalassemia (TDT).

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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