13th Oct 2015 11:25
LONDON (Alliance News) - Shire PLC said Tuesday the US Food and Drug Administration has granted cinryze a fast track designation for investigation in the treatment of antibody mediated rejection in patients receiving kidney transplants.
"There are currently no approved therapies for antibody mediated rejection, a life-threatening and debilitating condition which can manifest in patients receiving kidney transplants," said Shire Head of Research and Development Philip Vickers in a statement.
A fast track designation is designed to speed up the development and review of drugs that address serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Shire is planning a phase III study to evaluate cinryze with donor specific antibodies reduction therapy as a treatment for acute antibody mediated rejection in kidney transplant recipients.
Shares in Shire were up 0.5% at 4,403.00 pence Tuesday afternoon.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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