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news.Irish biopharmaceutical company Shire has obtained fast track designation from the United States Food and Drug Administration (FDA) for its investigation of CINRYZE (C1 esterase inhibitor [human]).
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CINRYZE received the designation for investigation in the treatment of antibody mediated rejection (AMR) in patients receiving kidney transplants.
The injectable prescription medicine is used to help prevent swelling and/or painful attacks in teenagers and adults with Hereditary Angioedema (HAE), a rare genetic disease which is characterized by recurrent sudden attacks of swelling of the skin or the mucous membranes.
Shire research and development head Philip Vickers said: "There are currently no approved therapies for Antibody Mediated Rejection, a life-threatening and debilitating condition which can manifest in patients receiving kidney transplants.
"The Fast Track designation represents an understanding of the significant unmet medical need for this condition."
In order to assess the efficacy of CINRYZE, as an adjunct to DSA reduction therapy, the company is planning a phase III multi-center, multi-national, randomized, double-blind, placebo-controlled study (SHP616-302) in the US, Europe and Canada.
The fast track program has been designed to aid the development and expedite the review of drugs that would address life-threatening conditions.
According to the company, the medicine is currently approved for, and should only be used for the treatment, routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.
In August, Shire signed an agreement with CINRYZE manufacturer Sanquin Blood Supply to provide the company access to its manufacturing technology and allowing it to source additional manufacturers to meet the increasing demand for the medicine.
Image: CINRYZE is used to help prevent swelling and/or painful attacks in teenagers and adults with HAE. Photo: courtesy of Mister GC/FreeDigitalPhotos.net