Astellas drug ‘may lead to infection-related mortality rise’

Astellas Pharma has been informed that its immunosuppressant Prograf (tacrolimus), administered mycophenolate mofetil (MMF) as a combined therapy for the prevention of organ rejection in patients that have received a kidney transplant may lead to a rise in infection-related mortality.

The compound, which is currently approved for the prophylaxis of organ rejection in heart, kidney and liver patients in the US, received a letter from the US Food and Drug Administration (FDA) which was approvable.

However, the letter also expressed concerns that administration of the compound with MMF at an initial dose of 2 g/day could increase infection-related mortality as a result of over-immunosuppression.

“The peer-reviewed literature and the United Network for Organ Sharing database do not show significant differences in survival rates among patients receiving the combination of MMF with Prograf or cyclosporine modified,” the company said.

Astellas added that it would work together with the FDA to settle its differences regarding the assessment of the relevant clinical trial data and gain approval for the compound’s supplemental new drug application.

In April 2006, Astellas announced that Prograf had been granted approval from the European Commission as a treatment to reduce the risk of transplant rejection in patients who have undergone heart transplants in the European Union.