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Strimvelis: treatment for adenosine deaminase deficiency (ADA-SCID) Talimogene laherparepvec (Imlygic): treatment for melanoma in patients who have recurring skin lesions [17] Tisagenlecleucel (Kymriah): treatment for B cell lymphoblastic leukemia [18] Valoctocogene roxaparvovec (Roctavian): treatment for hemophilia A [19] [20] [21]
Donislecel, sold under the brand name Lantidra, is a cellular therapy medication used for the treatment of type 1 diabetes. [3] [5] Donislecel is an allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells. Donislecel is administered as a single infusion into the hepatic (liver) portal vein. [5]
Voretigene neparvovec is an approved gene therapy to treat Leber's hereditary optic neuropathy. [94]: 1354 alipogene tiparvovec, a treatment for pancreatitis caused by a genetic condition, and Zolgensma for the treatment of spinal muscular atrophy both use an adeno-associated virus vector. [78]: 2647
The gene therapy will compete with Australia-based CSL Behring’s Hemgenix, a similar treatment that won FDA approval for hemophilia B in 2022. That drug has a similar list price of $3.5 million ...
Teplizumab, sold under the brand name Tzield, is a humanized anti-CD3 monoclonal antibody that is the first approved treatment indicated to delay the onset of stage 3 type 1 diabetes in people with stage 2 type 1 diabetes. [3] [4] [5] The Fc region of this antibody has been engineered to have Fc receptor non-binding (FNB) properties. [6]
The therapy, called exagamglogene autotemcel or exa-cel, uses new gene editing CRISPR technology, and is the first-of-its-kind product to reach the FDA for an approval decision. The FDA's ...
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