Astellas Pharma Inc. (Headquarters: Tokyo, President and CEO:
Masafumi Nogimori) announced today that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMEA)
has adopted a positive opinion recommending marketing approval of the
once-daily immunosuppressant FK506 Modified Release formulation
(generic name: tacrolimus) for the prevention of rejection in organ
transplantation.
FK506 Modified Release is a once-daily formulation of Astellas'
twice-daily formulation of Prograf(R) (tacrolimus), a leading
immunosuppressive agent marketed in over 70 countries around the world
for prevention of organ rejection in kidney, liver or heart transplant
recipients.
The availability of a once-daily formulation dosing regimen may
have the potential to increase patient compliance, and hence long-term
efficacy of immunosuppression, representing a step forward in the
management of transplant patients. This formulation is expected to be
at least as safe as the conventional formulation.
The CHMP based its positive opinion on its review of the
comprehensive data package for FK506 Modified Release, which
characterised its efficacy and safety profile. The indication for
FK506 Modified Release is: "Prophylaxis of transplant rejection in
adult kidney or liver allograft recipients. Treatment of allograft
rejection resistant to treatment with other immunosuppressive
medicinal products in adult patients".
Following the CHMP's positive opinion, the application will be
reviewed by the European Commission which has the authority to grant a
marketing authorisation for the European Union. This Commission
Decision is anticipated after approximately two and half months.
