In patients with recessive dystrophic epidermolysis bullosa (RDEB), both copies of the COL7A1 gene are mutated, resulting in the absence or low levels of biologically active C7 protein which form anchoring fibrils (AFs). The lack of AFs disrupts the connection between the epidermis and the dermis and causes skin fragility and other signs and symptoms of RDEB. Prademagene zamikeracel consists of a patient's own cells that have been gene-modified through RVV transduction to express the COL7A1 gene to produce the C7 protein. These cells are formed into cellular sheets for topical application onto wounds.
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Document | Type | Information Source | |
|---|---|---|---|
| ZEVASKYN Cellular sheet | MPI, US: SPL/PLR | FDA, National Drug Code (US) |
Prademagene zamikeracel is an active ingredient of these brands:
United States (US)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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