BRIEF—Mallinckrodt gains first ever approval for Uvadex

UK-incorporated Mallinckrodt 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.