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Shire to Present New Data to Help Advance Understanding of Rare Diseases
  • Research to be presented at ACAAI 2017 Annual Scientific Meeting, reinforcing Shire’s commitment to help patients living with hereditary angioedema and primary immunodeficiency

Cambridge, MA – Oct 23, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotech leader in rare diseases, announced today new data from the company’s hereditary angioedema (HAE) and primary immunodeficiency (PI) portfolios and pipeline will be presented at the 2017 Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Boston, Mass.

“The breadth of Shire data as well as our scientific symposia planned for this year’s ACAAI meeting underscores our Company’s commitment to furthering research for rare diseases,” said Howard Mayer, Head of Research and Development, Shire. “Shire’s strong presence at ACAAI is also a reflection of our leadership in HAE and PI. As a company, we’re very committed to these two therapeutic areas, so we feel a responsibility to help advance scientific and medical knowledge, with the ultimate aim of better addressing unmet patient needs.”

Key Shire data presentations at ACAAI 2017 include:

  • Icatibant Research
    • Longitudinal Natural History of Patients with Type I/II Hereditary Angioedema: Icatibant Outcome Survey Data (Poster Presentation 164, 5:40 p.m. ET, Friday, Oct. 27, 2nd Floor, Halls C-D, Hynes Convention Center)
  • HAE Research
    • Clinical and Demographic Characteristics of Patients with Hereditary Angioedema in the United States (Poster Presentation 174, 1:20 p.m. ET, Saturday, Oct. 28, 2nd Floor, Halls C-D, Hynes Convention Center)
  • Immune Globulin Research
    • Post-Authorization Safety Study of Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% Treatment in Patients with Primary Immunodeficiency Diseases (Poster Presentation 279, 9:55 a.m. ET, Sunday, Oct. 29, 2nd Floor, Halls C-D, Hynes Convention Center)
    • Adverse Events and Infusion Parameters of IG20Gly in Primary Immunodeficiency Patients Whose Pre-Study Treatment Was IVIG (Poster Presentation 281, 10:15 a.m. ET, Sunday, Oct. 29, 2nd Floor, Halls C-D, Hynes Convention Center)
  • Lanadelumab Research (Investigational product; subject to Regulatory approval)
    • Lanadelumab for Prevention of Attacks in Hereditary Angioedema: Results from the Phase 3 HELP™ Study, (Oral Presentation 34, 3:15 - 3:30 p.m. ET, Sunday, Oct. 29, Room 306, Hynes Convention Center)

The poster presentations are intended for scientific discussion only.

Shire will also be sponsoring a booth 2608 in the exhibition hall, as well as three events described below that focus on shared decision-making and treatment of PI, and approaches to patient management in HAE.

Events Sponsored by Shire

  • The Role of Sustained Kallikrein Inhibition: Driving Change in the Management of HAE
    Thursday, Oct. 26 from 6:00 – 8:00 p.m. ET
    Liberty Ballroom, Salons A-C, Sheraton Boston Hotel
  • Expert Insights on Shared Decision-Making in the Treatment of Primary Immunodeficiency
    Sunday, Oct. 29 from 6:30 – 8:30 p.m. ET
    Republic Ballroom, 2nd Floor, Sheraton Boston Hotel
  • HAE Product Theater – Approaches to HAE Patient Management
    Saturday, Oct. 28 from 3:05 – 3:30 p.m. ET
    Product Theater #1, Level 2, Halls C-D, Hynes Convention Center

INDICATION AND IMPORTANT SAFETY INFORMATION FOR FIRAZYR® (icatibant injection)

INDICATION
FIRAZYR® (icatibant injection) is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

IMPORTANT SAFETY INFORMATION
Laryngeal attacks can become life threatening. If you have an HAE attack of the throat (laryngeal attack), inject FIRAZYR and then go to the nearest hospital emergency room right away.

The most common side effects of FIRAZYR include:

  • redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site
  • fever
  • too much of an enzyme called transaminase in your blood
  • dizziness
  • nausea
  • headache
  • rash

These are not all of the possible side effects of FIRAZYR. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Tell your healthcare provider if you have any other medical conditions, if you are breastfeeding or plan to breastfeed, or if you are pregnant or planning to become pregnant. FIRAZYR has not been evaluated in pregnant or nursing women. You and your healthcare provider will decide if FIRAZYR is right for you.

If your symptoms continue or come back, you may repeat your FIRAZYR injection at least 6 hours apart. Do not use more than 3 doses of FIRAZYR in a 24-hour period.

Tiredness, drowsiness, and dizziness have been reported following the use of FIRAZYR. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.

For additional safety information, click for Prescribing Information and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution

What is HYQVIA?

  • HYQVIA is a liquid medicine containing immune globulin and Recombinant Human Hyaluronidase. HYQVIA contains IgG antibodies, collected from human plasma donated by healthy people. The antibodies help your body to fight off bacterial and viral infections. The hyaluronidase part of HYQVIA helps more of the immune globulin get absorbed into the body to fight infection.
  • HYQVIA is indicated for the treatment of Primary Immunodeficiency (PI) involving the humoral immune system in adults.
  • Safety and efficacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI.
  • HYQVIA is infused under the skin (subcutaneous).
  • If you and your healthcare professional decide that home self-infusion of HYQVIA is right for you, then be sure you get instructions and training from your healthcare professional before using HYQVIA at home.

Important Safety Information
What is the most important information that I should know about HYQVIA?

  • HYQVIA can cause blood clots.
  • Call your healthcare professional if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.
  • Your healthcare professional may perform blood tests regularly to check your IgG level.
  • With your consent, your healthcare professional may provide blood samples to Shire plc, to test for antibodies that may form against the hyaluronidase part of HYQVIA.
  • Do not infuse HYQVIA into or around an infected or red swollen area because it can cause infection to spread.
  • Talk to your healthcare professional if you become pregnant. Women who become pregnant during HYQVIA treatment are encouraged to enroll in the HYQVIA Pregnancy Registry by calling Medical Information at 1-866-424-6724.

Who should not take HYQVIA?
Do not take HYQVIA if you:

  • Are allergic to IgG, hyaluronidase, other blood products, or human albumin (in the hyaluronidase solution).
  • Have IgA deficiency with antibodies to IgA.

HYQVIA can cause serious side effects. Call your healthcare professional or go to your emergency department right away if you get:

  • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
  • Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of swelling in your brain.
  • Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
  • Pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s). These could be signs of a blood clot.
  • Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
  • Chest pain or trouble breathing, blue lips or extremities. These could be signs of a lung problem.

What are the possible or reasonably likely side effects of HYQVIA?

  • After HYQVIA infusion a temporary, soft swelling may occur around the infusion site, which may last 1 to 3 days, due to the volume of fluid infused. Mild or moderate pain, redness, swelling, or itching may occur at the site of infusion and generally go away in a few hours. Local reactions are less likely after the first few infusions.
  • The most common side effects of HYQVIA are headache, fatigue, nausea, fever, and vomiting.
  • Antibodies to the hyaluronidase component of HYQVIA were formed in some patients taking HYQVIA. It is not known if there is any long term effect. In theory, these antibodies could react with your body’s own PH20. PH20 is present in the male reproductive tract. So far, these antibodies have not been associated with increased or new side effects.

These are not all the possible side effects with HYQVIA. Talk to your healthcare professional about any side effects that bother you or that don’t go away.

Before starting HYQVIA, tell your healthcare professional if you:

  • Have or had any kidney, liver, or heart problems or history of blood clots because HYQVIA can make these problems worse.
  • Have IgA deficiency or a history of severe allergic reactions to IgG or other blood products.
  • Are pregnant, trying to become pregnant or are breast feeding.

You are encouraged to report suspected side effects by contacting FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Shire Drug Safety at 1-800-999-1785.

The risk information provided here is not comprehensive. To learn more, talk about HYQVIA with your healthcare provider or pharmacist. The FDA-approved patient labeling can be found accompanying this brochure.

For additional safety information, click for Prescribing Information and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] 

What is CUVITRU?

  • CUVITRU is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection.
  • CUVITRU is indicated for the treatment of primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.
  • CUVITRU is made from human plasma that is donated by healthy people. CUVITRU contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.
  • CUVITRU is given under the skin (subcutaneously).
  • Most of the time infusions under the skin are given at home by self infusion or by caregivers. Only use CUVITRU by yourself after you have been instructed by your healthcare provider.

Important Risk Information
What is the most important information that I should know about CUVITRU?
CUVITRU can cause the following serious reactions:

  • Severe allergic reactions causing difficulty in breathing or skin rashes
  • Decreased kidney function or kidney failure
  • Blood clots in the heart, brain, lungs, or elsewhere in the body
  • Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
  • Dark colored urine, swelling, fatigue, or difficulty breathing

Who should not use CUVITRU?
Do not use CUVITRU if you:

  • Are allergic to immune globulin or other blood products.
  • Have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA.

CUVITRU can cause serious side effects. Call your healthcare professional or go to the emergency department right away if you get:

  • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
  • Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
  • Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
  • Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
  • Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
  • Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.
  • Fever over 100ºF. This could be sign of an infection.

What are the possible or reasonably likely side effects of CUVITRU?

The following one or more possible side effects may occur at the site of infusion: mild or moderate pain, redness, and itching. These generally go away within a few hours, and are less likely after the first few infusions.

The most common side effects that may occur are: headache, nausea, fatigue, diarrhea, and vomiting.

These are not all the possible side effects. Talk to your healthcare professional about any side effects that bother you or that don’t go away.

For additional safety information, click for Prescribing Information and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About the Immunology Franchise
Shire’s immunology franchise has a strong legacy in developing therapies for people living with hereditary angioedema and primary immunodeficiency. Our broad portfolio includes commercial products and investigational therapies. We are committed to serial innovation and rely on our expertise to help fulfill unmet treatment needs for patients living with these diseases. Beyond our focus on developing novel treatments, we provide specialized services and support offerings that help meet the needs of our patients.

About Hereditary Angioedema
Hereditary Angioedema is a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide.1, 2 The condition results in recurring attacks of edema (swelling) in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.1, 3, 4 The swelling can be debilitating and painful, resulting in people with HAE taking an average of 20 days off work/education per year due to HAE. Attacks that obstruct the airways (asphyxiation) are potentially life-threatening.1, 3, 4, 5

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, these 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.6 It is estimated that as many as six million children and adults may be affected by PI worldwide.7

Learn more at shire.com

SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

For further information please contact:

Media

Elizabeth Kalinaekalina@shire.com+1 781 482 2713
Gwen Fishergfisher@shire.com+1 781 482 9649
Investor Relations  
Ian Karpikarp@shire.com+1 781 482 9018
Robert Coatesrcoates@shire.com+44 1256 894874

NOTES TO EDITORS

About Shire

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.

www.shire.com

References
1 Circardi M, Bork K, Caballero T, et al, on behalf of HAWK (Hereditary Angioedema International Working Group). Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an International Working Group. Allergy. 2012; 67(2):147-157.
2 Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.
3 Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.
4 Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.
5 Aygören-Pürsün et al. Socioeconomic burden of hereditary angioedema: results from the hereditary angioedema burden of illness study in Europe. Orphanet Journal of Rare Diseases. 2014, 9:99
6 Blaese RM, Bonilla FA, Stiehm ER, Younger ME, eds. Patient & Family Handbook for Primary Immunodeficiency Diseases. 5th ed. Towson, MD: Immune Deficiency Foundation; 2015.
7 Bousfiha AA et al. Primary immunodeficiency diseases worldwide: more common than generally thought. J Clin Immunol. 2013 Jan;33(1):1-7.

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