The US Food and Drug Administration (FDA) has granted fast-track designation for Irish biopharmaceutical firm Shire’s Cinryze (C1 esterase inhibitor [human]) for intravenous administration to treat antibody mediated rejection (AMR) in renal transplant recipients.
AMR is a condition that sometimes occurs in patients following solid organ transplantation and is started by the presence of donor specific antibodies (DSA) in the transplant recipient.
The company noted that Cinryze is being studied as an adjunct treatment to DSA reduction therapy in kidney transplant patients with acute AMR.
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 evaluate the efficacy of Cinryze, as an adjunct to DSA reduction therapy, the company is planning a Phase III study (SHP616-302) in the US, Europe and Canada.
Patient enrolment in this multi-centre, multi-national, randomised, double-blind, placebo-controlled trial will start by the end of this month.
The FDA fast-track programme has been designed to aid development and expedite the review of drugs that would address life-threatening conditions.
Cinryze is currently approved for routine prophylaxis against angioedema attacks in adolescent and adults with hereditary angioedema (HAE), a rare genetic disease.
The injectable prescription medicine is used to help prevent swelling or painful attacks in teenagers and adults with HAE.
HAE is characterised by recurrent sudden attacks of swelling of the skin or the mucous membranes.
In August, Shire signed an agreement with Cinryze manufacturer Sanquin Blood Supply to provide access to its manufacturing technology and allowing the Irish firm to source additional manufacturers to meet the increasing demand for the medicine.