Grafalon contains anti-human T-lymphocyte immunoglobulin and belongs to a group of medicines called immunosuppressants. Immunosuppressants are used to prevent the body from rejecting transplanted cells.
Grafalon is given before a stem cell transplantation (e.g. bone marrow transplantation) to prevent a condition called “graft versus host disease”. This is a common but serious complication that can develop after a stem cell transplant where there is a reaction of donated cells against a patient’s own tissue.
In solid organ transplantation, the addition of Grafalon induction to a standard triple or dual regimen reduces the risk of acute cellular rejection and possibly humoral rejection. It is an appropriate first choice in patients with moderate or high immunological risk, and may be used in low-risk patients receiving a CNI-sparing regimen from the time of transplant, or if early CS withdrawal is planned.
Grafalon is indicated for prevention of graft-versus-host disease (GvHD) after stem cell transplantation with matched, HLA-compatible, unrelated donors in adult patients with malignant hematological diseases in combination with standard therapy.
1979ATG-Fresenius® S (now Grafalon®) is manufactured for the first time
1981First clinical use in organ transplantation
1989First clinical use of the ATG-Fresenius® S polyclonal antibody in stem cell transplantation
2010FDA grants orphan drug status and fast track designation for the development of ATG-Fresenius® S for prevention of GVHD in the United States
2011German Health Authorities (PEI) approves ATG-Fresenius® S for GVHD prophylaxis in stem cell transplantation in Germany
2013Fresenius Biotech becomes Neovii
2014Neovii global headquarters are established in Rapperswil, Switzerland
2015ATG-Fresenius® S is re-branded and launched as GRAFALON®.
If you are interested in more information about our Grafalon product, proceed to the page dedicated especially to SPCs. For reading the full version of the SPCs, click here.