Shire announced that the Food and Drug Administration (FDA) has granted Fast Track designation to Cinryze (C1 esterase inhibitor [human]) as an adjunct to Donor Specific Antibodies (DSA) reduction therapy in renal transplant patients with acute Antibody Mediated Rejection (AMR).

Shire intends to initiate a Phase 3, multicenter, international, randomized, double-blind, placebo-controlled study (SHP616-302) to evaluate the efficacy of Cinryze as an adjunct to DSA reduction therapy (plasmapheresis, plasma exchange, and/or immune adsorption treatments and IVIG) in renal transplant recipients with acute AMR by the end of October 2015.

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Cinryze is an intravenous, humanized C1 esterase inhibitor currently approved for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

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