Shire completes decentralized procedure in EU to support approval for Cuvitru (IG 20mg/ml solution for subcutaneous injection)to treat immunodeficiency
Shire plc announced the successful completion of a decentralized procedure (DCP) to support approval by 17 authorities in Europe for Cuvitru (IG 20mg/ml solution for subcutaneous injection), a treatment for pediatric and adult patients with primary and certain secondary immunodeficiency disorders, a group of disorders in which part of the body's immune system is missing or does not function properly. It is estimated that as many as six million children and adults may be affected by primary immunodeficiencies (PI) worldwide.
Shire expects a regulatory decision for Cuvitru in the U.S. later this year in response to Baxalta's submission for licensing late in 2015 based on a separate Phase II/III study. The company expects to initiate additional global regulatory submissions in 2016.
With completion of the DCP, 17 authorities in EU member states mutually recognise approvability based on a scientific assessment of the product, and local marketing authorisations in Europe are expected to begin later this year, .
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