Zug, Switzerland. – September 23, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) will showcase data across its global leading immunoglobulin (IG) portfolio during the 17th Biennial Meeting of the European Society for Immunodeficiencies (ESID), taking place September 21-24, 2016 in Barcelona.
Presentations will include results of studies examining the safety, efficacy and tolerability profiles of Shire’s IG treatment options for immune deficiencies, including primary immunodeficiency (PI). Shire will complement the data on treatment options with research on the burden PI patients experience relating to their disease and treatment, as part of Shire’s commitment to delivering advanced, individualized treatment options for people with PI.
“ESID is an important opportunity for the scientific community to come together and reaffirm our shared commitment to advancing treatment options for people with immune deficiencies,” said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. “Shire is proud to be a leading voice in this conversation. We remain dedicated to understanding the patient journey and to driving innovation that addresses the evolving needs of patients.”
Highlights of Shire’s Presentations at ESID
Efficacy, Safety/Tolerability, and Pharmacokinetics of Human Immune Globulin Subcutaneous, 20%: Final Analysis of a Phase 2/3 Study in Patients with Primary Immunodeficiency Disease in North America
This data, published in the August issue of the Journal of Clinical Immunology, highlights final results from a Phase 2/3 study of Cuvitru, 20% IGSC. The prospective, open-label, non-controlled, multi-center study was conducted to assess the efficacy, safety, and pharmacokinetics (PK) of 20% IGSC among 74 North American patients at least two years old with PI. Data from a parallel study among patients in Europe was published in the September issue of Clinical and Experimental Immunology.
Cuvitru [Immune Globulin Subcutaneous (Human) 20% Solution], a treatment without proline for pediatric and adult patients with primary and certain secondary immunodeficiency disorders, is the latest treatment in Shire’s broad IG portfolio. In June 2016, Shire announced the successful completion of a decentralized procedure to support approval by 17 authorities in Europe for Cuvitru; the treatment was then approved in the United States earlier in September 2016.
Long-Term Safety, Efficacy, and Tolerability of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Immunoglobulin in Patients Aged <18 Years with Primary Immunodeficiency (PIDD)
This data evaluates the efficacy, safety and tolerability of HyQvia (Human Normal Immunoglobulin 10% and Recombinant Human Hyaluronidase) among patients 18 years of age and younger treated in HyQvia’s pivotal phase 3 study and its extension study. HyQvia is currently available for adults with PI in the United States and in 14 EU member states, where it is indicated for PI and certain secondary immunodeficiency disorders. In June 2016, Shire received the European Commission Decision for approval for the pediatric indication for HyQvia.
Interim Results of a Non-Interventional Post-Authorization Safety Study (PASS) on the Long-Term Safety of IGSC 10% Infusion Facilitated With Recombinant Human Hyaluronidase
This post-authorization safety study (PASS) was initiated in Europe in July 2014 to acquire additional safety data on HyQvia. The ongoing prospective, non-interventional, open label, uncontrolled, multicentre PASS is designed to evaluate the long-term local and systemic effects of HyQvia, as well as prescribed treatment regimens and treatment administration in routine clinical practice, in adults with PI, myeloma and chronic lymphocytic leukemia.
Understanding the Burden of Receiving Immunoglobulin Treatment for Primary Immunodeficiency Disorders: A Qualitative Study
People living with PI often face significant challenges relating to their disease and treatment. This qualitative research aims to better understand the burden of IG treatment in order to identify strategies to improve the lives of PI patients and their caregivers by tailoring treatment plans to individual needs. Researchers interviewed a diverse group of 52 PI patients receiving a range of type and mode of IG treatments via a purposive sampling method to learn more about their perspectives on the treatment experience.
About HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human Hyaluronidase) in Europe
Indication and Usage
In Europe today, HyQvia is indicated as replacement therapy in all patients 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 hematopoietic stem cell transplantation (HSCT).
For more information on HyQvia in Europe, please visit http://www.ema.europa.eu.
Important Risk Information
HyQvia must not be used by patients with a hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. HyQvia must not be used by patients with a systemic hypersensitivity to hyaluronidase or recombinant human hyaluronidase. HyQvia must not be used by patients with a hypersensitivity to any of the excipients, including glycine.
HyQvia must not be given intravenously.
Patients should be closely monitored and carefully observed for any adverse reactions throughout the infusion period, particularly patients starting with HyQvia treatment. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the adverse reaction.
In case of shock, standard medical treatment for shock should be implemented.
Thromboembolic events (e.g. myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism), renal dysfunction/failure, aseptic meningitis syndrome, and hemolysis have been observed with IG 10% administered intravenously and cannot be excluded with use of HyQvia. Thrombotic events and haemolysis have also been reported in association with the subcutaneous administration of immunoglobulin products.
Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
About Cuvitru 200 mg/ml solution for subcutaneous injection in Europe
After marketing authorization, Cuvitru 200 mg/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:
Detailed Important Risk Information
Hypersensitivity to the active substance or to any of the excipients.
Severe IgA deficiency and a history of hypersensitivity to human immunoglobulin treatment.
Cuvitru must not be given intravascularly or intramuscularly.
WARNINGS and PRECAUTIONS
If Cuvitru is accidentally administered into a blood vessel patients could develop shock.
The recommended infusion rate must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Certain adverse reactions may occur more frequently in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.
Potential complications can often be avoided by:
All other patients should be observed for at least 20 minutes after administration.
In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. Suspicion of severe hypersensitivity or anaphylactic-type reactions requires immediate discontinuation of the injection. The treatment required depends on the nature and severity of the adverse reaction.
In case of shock, standard medical treatment for shock should be implemented.
Thromboembolic events (e.g. myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism), renal dysfunction/failure, aseptic meningitis syndrome, hemolysis and interference with serological testing have been observed with IG administered intravenously and cannot be excluded with use of Cuvitru. Thrombotic events and hemolysis have also been reported in association with the subcutaneous administration of immunoglobulin products.
Human normal immunoglobulin is produced from human plasma and may carry a risk of transmitting infectious agents.
© 2016 Shire US Inc., Lexington, MA 02421. All rights reserved. 1-800-828-2088.
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
Baxalta, HyQvia and Cuvitru are registered trademarks of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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