MaaT013 Medicine 03 December 2024 Extended indication Maat013 monotherapy for salvage treatment of gastrointestinal Acute graft versus host disease in adults and elderly who are refractory to both steroids, the standard of care used as first-line treatment, and to ruxolitinib used as a second-line treatment Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance MaaT013 Domain Hematology Reason of inclusion New medicine (specialité) Main indication Graft versus Host Extended indication Maat013 monotherapy for salvage treatment of gastrointestinal Acute graft versus host disease in adults and elderly who are refractory to both steroids, the standard of care used as first-line treatment, and to ruxolitinib used as a second-line treatment Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Maatpharma Portfolio holder Mechanism of action Unknown Route of administration Rectal Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Suspensie voor rectaal gebruik. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date February 2025 Expected Registration March 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04769895 (ARES) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks