Cinryze Fast Tracked for Antibody Mediated Rejection
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.
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).
For more information call (800) 536-7878 or visit Shire.com.