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Takeda to Present Multiple New Data Analyses at 2023 AAAAI Annual Meeting, Including SPRING Study of TAKHZYRO® (lanadelumab-flyo) in Pediatric Patients With Hereditary Angioedema (HAE)

February 13, 2023

OSAKA, Japan and CAMBRIDGE, Mass., Feb 13, 2023 –  Takeda (TSE:4502/NYSE:TAK) today announced it will present seven abstracts related to its hereditary angioedema (HAE) treatment options at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, taking place February 24-27, 2023 in San Antonio, Texas.

“We are excited to share these findings which further support Takeda's leadership in gathering HAE evidence and reinforce our efforts to better understand the differing experiences of patients across diverse populations,” said Michael Denne, vice president U.S. Medical Affairs, Hematology and Rare Disease at Takeda. “We are dedicated to uncovering the most pressing patient needs and providing innovative solutions to help address the unpredictability and severity of HAE for all people impacted by this disease."

Takeda’s presentations at AAAAI will also be shared virtually via 5-minute audio summaries available in AAAAI’s online program. Abstracts can be accessed on AAAAI’s website, and presentation details include:

Lanadelumab-flyo in children 2 to <12 years of age:

Three new analyses of the open-label, multicenter, Phase 3 SPRING Study (NCT04070326), which evaluated the safety and pharmacokinetics of lanadelumab-flyo in children living with HAE 2 to <12 years of age, will be presented. Recently, Takeda announced the U.S. Food and Drug Administration’s approval of the expanded use of TAKHZYRO for prophylaxis to prevent attacks of HAE in pediatric patients 2 to <12 years of age, based on an extrapolation of efficacy data from the HELP Study with pharmacokinetic analyses as well as safety and pharmacodynamic data from the SPRING Study.1-3,8

  • Pharmacokinetics (PK), Pharmacodynamics (PD), and Exposure-Response (E-R) Analyses Confirm the Effectiveness of Lanadelumab in Patients 2 to <12 Years Old With Hereditary Angioedema (HAE). Abstract 403. Poster Presentation. Sunday, February 26, 2023, 9:45-10:45 a.m. CST, Convention Center, Lobby Level, Hall 2.
  • Efficacy of Lanadelumab at Fixed and Modified Dosing Regimens in Patients Aged 2 to <12 Years With Hereditary Angioedema (HAE) in the Phase 3, Open-label, Multicenter SPRING Studying the Phase 3, Open-label, Multicenter SPRING Study. Abstract 429. Poster Presentation. Sunday, February 26, 2023, 9:45-10:45 a.m. CST, Convention Center, Lobby Level, Hall 2.
  • Health-Related Quality of Life in Pediatric Patients With Hereditary Angioedema Receiving Lanadelumab: Exploratory Results From the SPRING Study. Abstract 427. Poster Presentation. Sunday, February 26, 2023, 9:45-10:45 a.m. CST, Convention Center, Lobby Level, Hall 2.

Lanadelumab-flyo real-world evidence:

A 24-month interim analysis of the Phase 4 observational, non-interventional, multicenter EMPOWER study (NCT03845400) provides real-world insights into the effectiveness of lanadelumab-flyo related to HAE attack rate reduction, quality of life and angioedema control after initiation.4

  • Effectiveness, Safety and Patient-Reported Outcomes (PROs) in Patients with Hereditary Angioedema (HAE) From the United States and Canada Treated with Lanadelumab: 24-Month Data From the EMPOWER Study. Abstract 405. Poster Presentation. Sunday, February 26, 2023, 9:45-10:45 a.m. CST, Convention Center, Lobby Level, Hall 2.

Lanadelumab-flyo in individuals living with HAE with Normal C1-Inhibitor (nC1-INH-HAE): New data from a retrospective chart review provides insights into efficacy of lanadelumab-flyo in patients with nC1-INH-HAE.5

  • Real-world Effectiveness of Lanadelumab in Patients With Normal C1-Inhibitor Hereditary Angioedema: A Multicenter Chart Review. Abstract 424. Poster Presentation. Sunday, February 26, 2023. 9:45 a.m.-10:45 a.m. CST, Convention Center, Lobby Level, Hall 2.

HAE disease burden and differences in HAE experience across racial and ethnic groups:

Two new analyses of real-world data from the Adelphi HAE Disease Specific Programme highlight the impact of HAE on patients <18 years of age and explore the differences between disease-related experiences of patients of different racial and ethnic backgrounds.6,7

  • Disease Burden and Physician-Reported Outcomes in Pediatric Patients With Hereditary Angioedema: Data From a Real-World Study. Abstract 435. Poster Presentation. Sunday, February 26, 2023. 9:45-10:45 a.m. CST, Convention Center, Lobby Level, Hall 2​.
  • Comparison of Hereditary Angioedema Among Patients of Different Races and Ethnicities in the United States: Data From a Real-World Study. Abstract 421. Poster Presentation. Sunday, February 26, 2023. 9:45-10:45 a.m. CST, Convention Center, Lobby Level, Hall 2​.

For additional details on the data presented across Takeda’s portfolio of HAE medicines at the AAAAI Annual Meeting, visit the annual meeting’s website. Takeda is also proud to sponsor the AAAAI Foundation 5K Run/Walk in support of allergy and immunology research. Visit Takeda at booth #1822.

About TAKHZYRO® (lanadelumab-flyo) Injection9

TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity and is indicated for prophylaxis to prevent attacks of HAE in patients 2 years of age and older. TAKHZYRO is intended for self-administration for patients 12 years of age and older, or administration by a caregiver with subcutaneous injection of solution in a single-dose prefilled syringe or in a single-dose vial. The patient or caregiver should be trained by a healthcare professional. For pediatric patients 2 to <12 years of age, TAKHZYRO should be administered by a healthcare provider or caregiver with a subcutaneous injection of solution in a single-dose prefilled syringe. Please see full prescribing information for recommended doses for each patient age group. It is not known if TAKHZYRO is safe and effective in children under 2 years of age.9

TAKHZYRO Safety Information for United States

INDICATION

TAKHZYRO (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥2 years of age.

IMPORTANT SAFETY INFORMATION

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.

Adverse Reactions: The most commonly observed adverse reactions (≥10%) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; dizziness; diarrhea; and myalgia. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.

Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <2 years of age have not been established.

No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.

To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-877-TAKEDA-7 (1-877-825-3327), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including information for patients.

About Hereditary Angioedema

Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful.10,11 Attacks that obstruct the airways, can cause asphyxiation and are potentially life threatening.11 HAE affects an estimated 1 in 50,000 people worldwide.10 It is often under recognized, under diagnosed and under treated.12

Takeda in Hereditary Angioedema

Hereditary angioedema (HAE), like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Every individual living with HAE is unique and by listening and reacting to their needs, we translate the insights we gain into innovative solutions – from diagnosis to ongoing management. Advancing the science is crucial to the way we operate and we are bold in our mission to accelerate diagnosis and develop treatments that will make a difference to the lives of people with HAE, their support networks and those medical professionals who care for them.

About Takeda

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI), with expertise in immune and inflammatory diseases. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.

Media Contacts:

Japanese Media

Jun Saito
[email protected]
+81 (0) 3-3278-3414

U.S. and International Media

Erin-Marie Beals
[email protected]
+ 1 781 336 9417

JC Molina
[email protected]

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Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

 


References

  1. Ahmed M, Wang Y, Yu M, Marier JF, and Bhattacharya I. Pharmacokinetics (PK), Pharmacodynamics (PD), and Exposure-Response (E-R) Analyses Confirm the Effectiveness of Lanadelumab in Patients 2 to <12 Years Old With Hereditary Angioedema (HAE). Abstract submitted to 2023 American Academy of Allergy Asthma & Immunology Annual Meeting 2023.
  2. Lumry W, Bernstein JA, Tachdjian R, et al. Efficacy of Lanadelumab at Fixed and Modified Dosing Regimens in Patients Aged 2 to <12 Years old with Hereditary Angioedema (HAE) in the Phase 3, Open-label, Multicenter SPRING Studying the Phase 3, Open-label Multicenter SPRING Study. Abstract submitted to 2023 American Academy of Allergy Asthma & Immunology Annual Meeting 2023.
  3. Watt M, Maurer M, Lumry WR, et al. Health-Related Quality of Life in Pediatric Patients With Hereditary Angioedema (HAE) Receiving Lanadelumab: Exploratory Results From the SPRING Study. Abstract submitted to 2023 American Academy of Allergy Asthma & Immunology Annual Meeting 2023.
  4. Wedner HJ, Bernstein JA, Betschel SD, et al. Effectiveness, Safety and Patient-Reported Outcomes (PROs) in Patients with Hereditary Angioedema (HAE) From the United States and Canada Treated with Lanadelumab: 24-Month Data From the EMPOWER Study. Abstract submitted to 2023 American Academy of Allergy Asthma & Immunology Annual Meeting 2023.
  5. Soteres D, Bernstein JA, Kanarek HJ, et al. Real-world Effectiveness of Lanadelumab in Patients With Normal C1-Inhibitor Hereditary Angioedema: A Multicenter Chart Review. Abstract 424 submitted to 2023 American Academy of Allergy Asthma & Immunology Annual Meeting 2023.
  6. Tachdjian R, Soteres D, Anderson J, et al. Disease Burden and Physician-Reported Outcomes in Pediatric Patients With Hereditary Angioedema: Data From a Real-World Study. Abstract 435 submitted to 2023 American Academy of Allergy Asthma & Immunology Annual Meeting 2023.
  7. Anderson, J, Craig T, Mellor J, et al. Comparison of Hereditary Angioedema Among Patients of Different Races and Ethnicities in the United States: Data From a Real-World Study. Abstract 421 submitted to 2023 American Academy of Allergy Asthma & Immunology Annual Meeting 2023.
  8. Maurer M, Lumry WR, Li HH, Aygoren-Pursun E, Busse PJ, Jacobs J, Nurse C, Yu M. Efficacy and Safety of Lanadelumab in Pediatric Patients Aged 2 to <12 years With Hereditary Angioedema: Results From the Open-Label, Multicenter Phase 3 SPRING Study. Presented July 1-3, 2022 Prague, Czech Republic at European Academy of Allergy and Clinical Immunology Hybrid Congress 2022. 
  9. TAKHZYRO® (lanadelumab-flyo) injection. U.S. Prescribing Information.
  10. Busse PJ, Christiansen SC, Riedl MA, et al. US HAEA Medical Advisory Board 2020 Guidelines for the Management of Hereditary Angioedema. J Allergy Clin Immunol Pract. 2021 Jan;9(1):132-150.e3. doi: 10.1016/j.jaip.2020.08.046.
  11. Banerji A. Hereditary angioedema: Classification, Pathogenesis, and Diagnosis. Allergy Asthma Proc. 2011;32:403–407. doi:10.2500/aap.2011.32.3492.
  12. Longhurst HJ, Bork K. Hereditary Angioedema: An Update on Causes, Manifestations, and Treatment. Br J Hosp Med. 2019;80(7):391-398. doi:10.12968/hmed.2019.80.7.391.