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news.Astellas Pharma has said the European Medicines Agency has recommended marketing approval for a new formulation of its immunosuppressant for the prevention of rejection in organ transplantation.
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The new formulation is a modified release, once-daily formulation of Prograf, a leading immunosuppressive agent marketed around the world for prevention of organ rejection in kidney, liver or heart transplant recipients.
Astellas believes 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 agency based its positive opinion on its review of the comprehensive data package which characterized its efficacy and safety profile of the once-daily formulation.
Following the positive opinion, the application will be reviewed by the European Commission which has the authority to grant a marketing authorization for the European Union.