Astellas Pharma receives positive CHMP opinion for FK506

Astellas Pharma has announced that the company has received appositive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for FK506 modified release formulation (tacrolimus) to prevent rejection in patients that have undergone organ transplantation.

FK506 modified release is a once-daily immunosuppressant, an altered version of Prograf, the firm’s twice-daily formulation of tacrolimus used worldwide in patients who have received heart, liver and kidney transplants.

Following the receipt of the positive approval from the CHMP, the European Commission will review the application and decide on the granting of marketing authorisation for the compound in the European Union.

The CHMP stated that the indication of FK506 modified release is: “Prophylaxis of transplant rejection in adult kidney or liver allograft recipients [and] treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.”

Astellas Pharma comments that a once-daily foumulation of tacrolimus could increase compliance from patients and thus enhance the long-term efficacy of immunosuppression in transplant patients.

In April 2006, the company reported that the European Commission had approved Prograf as an immunosuppressant for use in patients who have undergone heart transplant surgery in the EU.