Leflunomide - Orphan Drug Status

Orphan Drug Status

Leflunomide has recently been assigned orphan drug status for the prevention of solid-organ rejection after allograft transplantations when co-administered with commonly used first-line agents (USA only). Most experience exists with liver and renal transplantations. The efficacy and safety of leflunomide has not been completely assessed so far in well-controlled and adequate studies.

Teriflunomide shows, in addition to the expected profound immunosuppressive potency, limited antiviral activity against CMV (cytomegalovirus). CMV infections endanger eyesight (retinitis) or even the lives of transplant patients (systemic infections) under conventional immunosuppressive therapy regimes.

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