Japanese drugmaker Astellas has launched its new immunosuppressant Advagraf in its first European markets - the UK and Germany - for patients undergoing organ transplantation.
Advagraf is a once-daily version of Astellas’ best-selling drug Prograf (tacrolimus), and was approved by the European Commission for use in kidney and liver transplants in April.
The new formulation is a modified-release version of Prograf, which is used to prevent organ rejection and is currently given twice a day. According to Astellas, Advagraf is expected to boost long-term compliance with its more convenient dosing option, and may have the potential to cut the incidence of chronic rejection and graft loss.
A recent study in kidney transplant recipients, published in the Journal of the American Society of Nephrology, demonstrated a statistically-significant improvement in adherence to therapy in patients on the once-daily dosing regimen compared with those on twice-daily dosing, the company said in support of its better compliance claim.
Advagraf’s green light in Europe was very good news for Astellas, given that its predecessor will lose patent protection in just two years. But, unfortunately for the group, the path to approval has not run smooth in the USA, where the Food and Drug Administration issued a non-approvable letter for the drug in January.