STAINES-UPON-THAMES, United Kingdom , Oct. 31, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today 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.
The TGA approval marks the first combined indication label and the first regulatory approval in the world for UVADEX in conjunction with the THERAKOS Photopheresis System for the treatment of chronic graft versus host disease in adults.
"The TGA approval of UVADEX with the Therakos ECP platform opens up new treatment options for patients with these challenging conditions," said Steven Romano , M.D., Executive Vice President and Chief Scientific Officer, Mallinckrodt . "The cGvHD indication is also an important milestone for Mallinckrodt , confirming the potential benefit of this therapeutic option for patients who are refractory to or intolerant of steroid treatments."
Date of first approval: 16 September 2019 . Date of revision: 11 October 2019 .
