Data reveals key findings on the tolerability of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] for patients, regardless of treatment infusion volume and rates
Lexington, Mass. – November 12, 2016 Shire plc (LSE: SHP, NASDAQ: SHPG) will present additional data supporting the tolerability of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in patients two years of age and older with primary immunodeficiency (PI) diseases in North America at the 2016 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology in San Francisco. The presentation will highlight key findings on established tolerability of CUVITRU for PI patients who received CUVITRU in the Phase II/III North American clinical trial. Of note, increased infusion volumes and rates were not associated with an increase in causally-related local adverse reactions, and infusions were well-tolerated during onboarding and throughout the study.
“As the latest treatment to be added to Shire’s industry-leading IG portfolio, CUVITRU exemplifies our commitment to reducing the burden of PI for patients living with this challenging, often debilitating condition,” said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. “As a customizable therapy, CUVITRU offers patients and physicians multiple options to tailor their IG treatment to fit their needs and preferences, such as varying the volume/site, the dosing frequency, and infusion rate.”
PI is a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly, in some cases making it more difficult to fight off infections.1,2 PI affects six million people worldwide, of which approximately 250,000 reside in the U.S.3,4 Most people with PI have abnormally low or nonexistent IG levels, and may benefit from IG replacement treatment to help the body prevent infections. Since it only offers temporary protection, many people with PI require IG replacement treatment throughout their lives.5
“ACAAI’s annual meeting is a welcome opportunity for the immunology community to learn more about the benefits CUVITRU can offer patients with PI looking to take control of their IG treatment,” said Sudhir Gupta, MD, PH.D., MACP, Chief of Basic and Clinical Immunology, and Director, Programs in Primary Immunodeficiency and Aging, at University of California, Irvine. “The data reinforces that patients can work with their physician to individualize their dosage and administration schedule, allowing for greater flexibility and control within their normal daily routine.”
As demonstrated in the clinical trials, CUVITRU offers patients the ability to infuse up to 60 mL (12 grams) per site and up to 60 mL per hour per site, as tolerated, allowing for fewer infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments. The data to be presented at ACAAI offers additional evidence that patients achieved the increased rate and volume, without compromising tolerability. Approximately 72% of patients in the clinical trial achieved the maximum infusion rate of 60 mL per hour per site, occurring after a median time of 3 infusions with no association between infusion rate and causally related local adverse event (AE) rates. Importantly, 99.8% infusions of CUVITRU were completed without a rate reduction, interruption, or discontinuation indicating the infusions were well tolerated. In addition, 75% of infusions delivered a volume of 30 mL per site or greater, with no association between volume per site and causally-related local AEs.6 The full clinical trial results can be found in Journal of Clinical Immunology.
CUVITRU is the latest product in Shire’s industry-leading IG portfolio. The U.S. Food and Drug Administration approved CUVITRU in September 2016. Shire also received successful completion of a decentralized procedure to support CUVITRU approval by 17 authorities in Europe in June 2016. The company expects to initiate additional global regulatory submissions for CUVITRU in late 2016 and 2017.
For more information on CUVITRU, please visit www.cuvitru.com.
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.1 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 inherited and genetically determined, it is called primary immune deficiency.2
About CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution]
CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.
CUVITRU is for subcutaneous infusion only.
Detailed Important Risk Information
BOXED WARNING: THROMBOSIS
Thrombosis may occur with immune globulin products, including CUVITRU. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.
For patients at risk of thrombosis, administer CUVITRU at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
CUVITRU is contraindicated in patients who have had an anaphylactic or severe systemic hypersensitivity reaction to the subcutaneous administration of human immune globulin and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human immune globulin treatment.
WARNINGS and PRECAUTIONS
Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human immune globulin. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Renal Dysfunction/Failure: Monitor renal function and urine output and consider lower, more frequent dosing in patients who are at risk of developing renal dysfunction because of pre-existing renal insufficiency or predisposition to acute renal failure.
Thrombosis: Monitor for signs and symptoms of thrombosis and assess blood viscosity for those at risk for hyperviscosity.
Aseptic Meningitis Syndrome (AMS): Monitor for clinical signs and symptoms of AMS.
Hemolysis: Monitor for clinical signs and symptoms of hemolysis and delayed hemolytic anemia.
Transfusion-Related Acute Lung Injury (TRALI): Monitor for pulmonary adverse reactions associated with TRALI.
Transmittable Infectious Agents: Because CUVITRU is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses and other pathogens. No confirmed cases of transmission of viral diseases or variant Creutzfeldt-Jakob disease (vCJD) have been associated with CUVITRU.
Interference with Laboratory Tests: False positive serological test results, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.
The most common adverse reactions observed in clinical trials in ≥ 5% of patients were: local adverse reactions, systemic adverse reactions including headache, nausea, fatigue, diarrhea, and vomiting.
Please see Full Prescribing Information, including Boxed Warning regarding Thrombosis, available at: http://www.shirecontent.com/PI/PDFS/Cuvitru_USA_ENG.pdf.
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates. CUVITRU is a trademark or registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.
1 Picard C, Al-Herz W, et al. Primary Immunodeficiency Diseases: an Update on the Classification from the International Union of Immunological Societies Expert Committee for Primary Immunodeficiency. J Clin Immunol. 2015 Nov;35(8):696-726.
5 Immune Deficiency Foundation, “Immunoglobulin Therapy & Other Medical Therapies for Antibody Deficiencies:” http://primaryimmune.org/treatment-information/immunoglobulin-therapy/. October 19, 2015.
6 Gupta S. “Tolerability of the New Human Immune Globulin Subcutaneous, 20% Preparation in Primary Immunodeficiency Diseases” Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology, San Francisco. November 10-14, 2016.
Click here for the PDF version of this press release.
|Sarah Elton-Farrfirstname.lastname@example.org||+44 1256 894157|
|Ian Karpemail@example.com||+1 781 482 9018|
|Robert Coatesfirstname.lastname@example.org||+44 1256 894874|
|Gwen Fisheremail@example.com||+1 484 595 9836|
|Debbi Fordfirstname.lastname@example.org||+1 617 949 9083|
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.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including those risks outlined in “ITEM 1A: Risk Factors” in Shire’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.