ADVAGRAF PROGRAF

ots.at: Advagraf(R) Now Approved Across Europe as a Once-Daily Immunosuppressant in Organ Transplantation = London (ots/PRNewswire) - Astellas announced today that the European Commission has approved the immunosuppressant Advagraf(R) (generic name: tacrolimus, prolonged release) for prophylaxis of transplant rejection in adult kidney or liver allograft recipients and for the treatment of allograft rejection resistant to treatment with other immunosuppressive drugs in adult patients throughout the European Union (EU). Advagraf(R) combines the proven safety and high efficacy of Prograf(R), the leading immunosuppressive agent of care for the prevention of rejection in organ transplantation, in a prolonged release formulation that offers patients a convenient, once-daily dosing option. "A number of studies indicate that non-adherence to medication has become a key concern in transplant patients and the availability of a once-daily dosing regimen represents a highly desirable step forward in patient management," said Professor Johannes van Hooff, Professor of Medicine, Department of Nephrology at University Hospital Maastricht, The Netherlands. "Advagraf(R) has the potential to improve adherence and hence the long-term efficacy of immunosuppression." Transplant patients are prescribed a variety of medications that require multiple dosing at various times throughout the day. Because of the variety of medications and the complicated dosing schedule, non-compliance rates for transplant recipients can be over 45 per cent(1), resulting in acute and chronic rejection and graft loss(2). A recent study in kidney transplant recipients was able to show a statistically significant improvement in adherence associated with once-daily dosing compared with twice-daily dosing regimens(3). Clinical data overview The EU approval of Advagraf(R) is based on the results of Phase II trials in liver, kidney and heart transplant patients (n=613) and a phase III trial(4) (n=638).