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FDA grants fast track designation to Shire’s Cinryze

Kidney transplant treatment in line for regulatory assistance

Shire's Ceniryze has been given fast track status by the FDA for patients in renal transplantation.

Ceniryze (C1 esterase inhibitor [human]) is used as an intravenous drug for patients with antibody mediated rejection (AMR) in renal transplant recipients.

Philip Vickers, head of research and development at Shire, 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. Shire looks forward to working closely with the FDA as we continue to study Cinryze as a potential treatment option for these patients.”

Meanwhile, Shire is also planning a phase III study (SHP616-302) to evaluate the efficacy of Cinryze as an adjunct to DSA reduction therapy for the treatment of acute AMR in kidney transplant patients. The study will open for enrolment at the end of this month and will be conducted in the US, Europe and Canada.

Cinryze is currently only approved for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE) and is used to prevent swelling or painful episodes.

HAE is characterised by recurrent sudden attacks of swelling of the skin or the mucous membrane.

At the end of 2013, Shire signed a deal with US company Viropharma for around $4.2bn which gave the company rights to Cinryze. In the first six months of 2014 Cinryze generated sales of $215.5m.

The FDA's fast track designation is designed to facilitate the development and expedite the review of drugs that address serious life threatening or debilitating conditions for which there is an unmet medical need. 

Fast track status also increases interaction between drug companies and the FDA, improving the chances of selected drugs going on to receive priority review. 

Article by
Nikhil Patel

19th October 2015

From: Regulatory



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