Shire's Cuvitru is a big step closer to a roll-out in Europe, after the firm completed the decentralised procedure (DCP) to support the drug's approval in the region to treat patients with primary and certain secondary immunodeficiency disorders.
Cuvitru is a new subcutaneous immunoglobulin treatment that does not contain the amino acid proline. Shire says it offers patients a new therapeutic option to meet their needs, "particularly related to the number of infusion sites and infusion time".
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, the firm said.
"With the completion of the assessment procedure, we can move forward with seeking country approvals of Cuvitru in Europe as we continue to build a comprehensive portfolio of IG treatments that can address the distinct needs of people with PI around the world," said Philip Vickers, Shire's head of R&D.
It is estimated that as many as six million children and adults worldwide may be affected by primary immunodeficiencies, a group of more than 300 disorders in which part of the body's immune system is missing or does not function properly.
A regulatory decision for Cuvitru in the US is expected later this year in response to Baxalta's submission for licensing.
Shire's is currently in the process of acquiring Baxalta for around $32 billion to create "the global leader in rare diseases" has now been approved by both sets of shareholders.