Following a meeting held on 16-19 March 2009 The European Medicines Agency’s (EMEA) Committe for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorisation for Modigraf.
Modigraf (tacrolimus), from Astellas Pharma Europe BV is indicated for the prophylaxis and treatment of transplant rejection in adult and paediatric kidney, liver or heart allograft recipients.
The EMEA review began on 26 December 2007, with an active review time of 205 days. The committee said that the main benefit of Modigraf was that it offers an oral formulation of tacrolimus suitable for children and for seriously ill adults who have difficulty swallowing capsules.
Tacrolimus is a macrolide immunosuppressant that inhibits the activation of serine theronine phosphate, calcinerurin, in T-lymphocytes in order to suppress T-cell activation and the subsequent generation of cytotoxic lymphocytes, thereby down-regulating processes leading to acute graft rejection.