Uvadex is approved in Australia for use with the Therakos Cellex Photopheresis System for treatment of chronic graft versus host disease (cGvHD) and skin manifestations of cutaneous T-cell lymphoma in adults. Mallinckrodt
Mallinckrodt Plc announced that Uvadex (methoxsalen) has received regulatory approval in Australia by the Therapeutic Goods Administration (TGA) for extracorporeal administration with the Therakos Cellex Photopheresis System. The treatment is indicated for steroid-refractory and steroid-intolerant chronic graft versus host disease (cGvHD) in adults following allogeneic hematopoietic stem cell (HSC) transplantation.
The TGA also approved Uvadex in conjunction with the THERAKOS CELLEX Photopheresis System for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.
Comment: This approval marks first combined indication label and first regulatory approval in the world for Uvadex in conjunction with the Therakos extracorporeal photopheresis (ECP) System for the treatment of chronic GvHD in adults-
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