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news.Shire has completed 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.
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It is estimated that as many as six million children and adults may be affected by primary immunodeficiencies (PI) worldwide.1
With the addition of Cuvitru following the completion of the combination with Baxalta, Shire has the broadest immunoglobulin (IG) portfolio with intravenous, conventional and subcutaneous treatment options.
Cuvitru is a new IG treatment that does not contain proline; it offers patients a new therapeutic option to meet their needs, particularly related to the number of infusion sites and infusion time.
With the completion of the DCP, the 17 authorities mutually recognize approvability based on a scientific assessment of the product, and local marketing authorizations in Europe are expected to begin later in 2016.
Regulatory evaluation for Cuvitru was based on the positive results of a Phase 2/3 study that evaluated the efficacy, safety, tolerability and pharmacokinetics of IGSC 20% in European patients with PI. The study met its primary endpoint that measured the rate of validated acute serious bacterial infections.
"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 J. Vickers, Ph.D., Head of Research and Development, Shire.
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.
About Primary Immunodeficiency
Primary immunodeficiencies (PI) are a group of more than 300 disorders in which part of the body’s immune system is missing or does not function properly.
Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person’s immune system is absent or dysfunctional, the individuals are susceptible to infections, and it may take longer to recover from infections. When a defect in the immune system is genetically determined, it is called primary immune deficiency.3 It is estimated that as many as six million children and adults may be affected by PI worldwide.
About Cuvitru 20mg/ml solution for subcutaneous injection in Europe
After marketing authorization, Cuvitru 20mg/ml solution for subcutaneous injection will be indicated as a subcutaneous administration (SCIg) replacement therapy in adults, and children and adolescents (0 – 18 years) in:
Primary immunodeficiency syndromes with impaired antibody production.
Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.
Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.
Hypogammaglobulinaemia in patients pre- and post- allogeneic haematopoietic stem cell transplantation (HSCT).