Enforcement Report - Week of January 31, 2024
– In a rare dual-review process, two independent advisory committees to the Australian Minister for Health recommend reimbursement based on a favorable clinical and cost-effectiveness comparison –
Mallinckrodt plc, a global biopharmaceutical company, and Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies have announced that UVADEX® (methoxsalen) has received regulatory approval in Australia by the Australian Therapeutic Goods Administration (TGA) for extracorporeal administration with the THERAKOS® CELLEX® Photopheresis System.
Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, and Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, today announced that UVADEX® (methoxsalen) has received regulatory approval in Australia by the Australian 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.
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