Prograf gets FDA OK for heart transplant care

The US Food and Drug Administration says it has approved Japanese drugmaker Astellas Pharma's immunosuppressant Prograf (tacrolimus hydrate) for the prevention of graft rejection in recipients of heart transplants. This drug, which has a mechanism similar to the commonly-used product cyclosporine, was first approved by the FDA for the prophylactic prevention of organ rejection in kidney and liver transplants in May 1997 (Marketletters passim).

The FDA added that its decision is based on data from two trials that assessed the product's safety and efficacy, one European, the other USA-based. The European program, which examined Prograf in comparison with cyclosporine, showed that, 18 months after surgery, 91.7% of patients in the Prograf-treated cohort had survived, versus 89.8% in the cyclosporine group. The US study, which made the assessment of patient and graft survival 12 months post surgery, showed that Prograf conferred a 93.5% survival rate.

The FDA added that Prograf is associated with renal impairment, infection, diabetes mellitus and increased neurotoxicity and, like most immunosuppressive drug regimes used in solid organ transplantation, is linked to an increased risk of malignancies and non-melanoma skin cancer.