The European Medicines Agency (EMA) Has Approved an Additional Subcutaneous Administration Option for TAKHZYRO® (lanadelumab) for Patients Aged 12 Years and Above with Recurrent Attacks of Hereditary Angioedema (HAE)
Takeda (NYSE: TAK) has received EMA approval for an additional subcutaneous administration option of TAKHZYRO® (lanadelumab) for HAE patients aged 12 years and above. The new 2 mL pre-filled pen joins existing delivery options including 150 mg and 300 mg pre-filled syringes and 300 mg vials.
The approval expands treatment options for Hereditary Angioedema (HAE), a rare condition affecting approximately 1 in 50,000 people worldwide. TAKHZYRO is approved in the EU for routine prevention of recurrent HAE attacks in patients aged 2 years and older. The new pre-filled pen contains 300 mg of lanadelumab in 2 mL solution, with approval supported by clinical study data.
Takeda (NYSE: TAK) ha ricevuto l'approvazione dell'EMA per un'opzione aggiuntiva di somministrazione sottocutanea di TAKHZYRO® (lanadelumab) per i pazienti con HAE di età pari o superiore a 12 anni. Il nuovo penna pre-riempita da 2 mL si aggiunge alle opzioni di somministrazione esistenti, tra cui siringhe pre-riempite da 150 mg e 300 mg e fiale da 300 mg.
L'approvazione amplia le opzioni di trattamento per l'Angioedema Ereditario (HAE), una condizione rara che colpisce circa 1 persona ogni 50.000 nel mondo. TAKHZYRO è approvato nell'UE per la prevenzione di routine degli attacchi ricorrenti di HAE in pazienti di età pari o superiore a 2 anni. La nuova penna pre-riempita contiene 300 mg di lanadelumab in soluzione da 2 mL, con approvazione supportata da dati di studi clinici.
Takeda (NYSE: TAK) ha recibido la aprobación de la EMA para una opción adicional de administración subcutánea de TAKHZYRO® (lanadelumab) para pacientes con HAE de 12 años o más. El nuevo bolígrafo precargado de 2 mL se une a las opciones de entrega existentes, que incluyen jeringas precargadas de 150 mg y 300 mg y viales de 300 mg.
La aprobación amplía las opciones de tratamiento para el Angioedema Hereditario (HAE), una condición rara que afecta aproximadamente a 1 de cada 50,000 personas en todo el mundo. TAKHZYRO está aprobado en la UE para la prevención rutinaria de ataques recurrentes de HAE en pacientes de 2 años o más. El nuevo bolígrafo precargado contiene 300 mg de lanadelumab en una solución de 2 mL, con aprobación respaldada por datos de estudios clínicos.
다케다 (NYSE: TAK)는 12세 이상의 HAE 환자를 위한 TAKHZYRO® (라나델루맙)의 추가 피하 투여 옵션에 대해 EMA 승인을 받았습니다. 새로운 2mL 프리필드 펜은 150mg 및 300mg 프리필드 주사기와 300mg 바이알을 포함한 기존 투여 옵션에 추가됩니다.
이번 승인은 전 세계적으로 약 50,000명 중 1명에게 영향을 미치는 희귀 질환인 유전성 혈관부종 (HAE)의 치료 옵션을 확장합니다. TAKHZYRO는 2세 이상의 환자에서 반복적인 HAE 발작의 일상적인 예방을 위해 EU에서 승인되었습니다. 새로운 프리필드 펜은 2mL 용액에 300mg의 라나델루맙을 포함하고 있으며, 승인은 임상 연구 데이터를 기반으로 지원됩니다.
Takeda (NYSE: TAK) a reçu l'approbation de l'EMA pour une option supplémentaire d'administration sous-cutanée de TAKHZYRO® (lanadelumab) pour les patients atteints d'HAE âgés de 12 ans et plus. Le nouveau stylo prérempli de 2 mL s'ajoute aux options de délivrance existantes, y compris des seringues préremplies de 150 mg et 300 mg ainsi que des flacons de 300 mg.
Cette approbation élargit les options de traitement pour l'Angioedème Héréditaire (HAE), une condition rare touchant environ 1 personne sur 50 000 dans le monde. TAKHZYRO est approuvé dans l'UE pour la prévention routinière des attaques récurrentes d'HAE chez les patients âgés de 2 ans et plus. Le nouveau stylo prérempli contient 300 mg de lanadelumab dans une solution de 2 mL, avec une approbation soutenue par des données d'études cliniques.
Takeda (NYSE: TAK) hat die EMA-Zulassung für eine zusätzliche subkutane Verabreichungsoption von TAKHZYRO® (Lanadelumab) für HAE-Patienten ab 12 Jahren erhalten. Der neue 2-mL- vorgefüllte Pen ergänzt die bestehenden Verabreichungsoptionen, darunter vorgefüllte Spritzen mit 150 mg und 300 mg sowie 300 mg Fläschchen.
Die Genehmigung erweitert die Behandlungsoptionen für hereditäres Angioödem (HAE), eine seltene Erkrankung, die weltweit etwa 1 von 50.000 Menschen betrifft. TAKHZYRO ist in der EU zur routinemäßigen Prävention von wiederkehrenden HAE-Anfällen bei Patienten ab 2 Jahren zugelassen. Der neue vorgefüllte Pen enthält 300 mg Lanadelumab in einer 2-mL-Lösung, wobei die Genehmigung durch klinische Studiendaten unterstützt wird.
- EMA approval expands delivery options for TAKHZYRO treatment
- Additional administration option provides more flexibility for patients aged 12+
- None.
Insights
The EMA approval of TAKHZYRO's pre-filled pen represents a strategic enhancement to Takeda's HAE franchise. With an estimated global HAE prevalence of 1 in 50,000, this translates to a specialized market of approximately 160,000 patients in Europe alone. The pre-filled pen approval is particularly significant for three key reasons:
Market Expansion & Revenue Protection: The new delivery option strengthens Takeda's competitive moat in the HAE space. By offering multiple administration options (pre-filled pen, pre-filled syringe, and vial), Takeda creates higher switching costs for patients and healthcare providers, potentially protecting its market share against future competitors. The pre-filled pen specifically addresses the growing demand for user-friendly self-administration devices, which typically command premium pricing.
Healthcare Economics: The pre-filled pen format typically improves treatment adherence by reducing administration complexity. Higher adherence rates generally lead to better patient outcomes, fewer emergency interventions, and reduced healthcare costs. This value proposition strengthens Takeda's position in pricing negotiations with healthcare payers.
Strategic Portfolio Optimization: This approval aligns with Takeda's broader rare disease strategy, where the company has built significant expertise and commercial infrastructure. The expanded delivery options create a more complete product ecosystem, potentially increasing the lifetime value per patient while addressing specific needs across different patient segments.
- TAKHZYRO Solution for Injection in 2 mL Pre-Filled Pen is Now Approved to Facilitate Subcutaneous Administration in Adolescent (Aged 12 Years and Above) and Adult Patients with HAE.1
- The Pre-Filled Pen Option is Designed to Allow for An Individualized Treatment Approach for Adolescent and Adult HAE Patients.
- In the EU, TAKHZYRO is Approved for Routine Prevention of Recurrent HAE Attacks in Patients Aged 2 Years and Older.1
The additional subcutaneous administration option expands Takeda's offering in this space, showing dedication to the HAE community while providing individualized treatment options to support patients with a life-threatening disease, by helping to reduce HAE burden and improving their Quality of Life.
"HAE affects an estimated 1 in 50,000 people worldwide and is often under recognised, under diagnosed and under treated.3 We welcome the swift approval by the EMA on this additional subcutaneous administration option," said Irmgard Andresen, Global Medical Lead HAE at Takeda. "HAE patients 12 years and older now have an additional individualized treatment option available to them."
TAKHZYRO® (lanadelumab) is currently approved as 150 mg solution for injection in pre-filled syringe, 300 mg solution for injection in pre-filled syringe, and 300 mg solution for injection in vial.1 This approval for an additional subcutaneous administration option, TAKHZYRO® 300 mg solution for injection in pre-filled pen, containing 300 mg of lanadelumab in 2 mL of solution, was supported by a clinical study.2
Takeda is dedicated to providing innovative treatment options to support patients, particularly those from underserved communities, and continues its leadership in HAE treatment, supported by a noteworthy data pool from historical engagement in this area.
Notes to editors:
About HAE
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.4 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.5 HAE affects an estimated 1 in 50,000 people worldwide.3 It is often under recognised, under diagnosed and under treated.3
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 HAE patients, their support networks and those medical professionals who care for them.
About Lanadelumab (TAKHZYRO®)1
Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for routine prevention of recurrent attacks of HAE in patients aged 2 years and older.1 It was studied in one of the largest prevention studies in HAE with the longest active treatment duration, and Lanadelumab consistently demonstrated HAE attack reduction. Lanadelumab is formulated for subcutaneous administration and has a half-life of approximately two weeks.1 Lanadelumab is intended for self-administration or administration by a caregiver once trained by a healthcare professional.1
Product Name | TAKHZYRO 150 mg solution for injection in pre-filled syringe; TAKHZYRO 300 mg solution for injection in pre-filled syringe; TAKHZYRO 300 mg solution for injection in pre-filled pen; TAKHZYRO 300 mg solution for injection |
Generic Name | Lanadelumab |
Indication | TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 2 years and older. |
Posology and Administration | This medicinal product should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). The recommended starting dose is 300 mg lanadelumab every 2 weeks. In patients who are stably attack free on treatment, a dose reduction to 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight. In patients with a body weight less than 40 kg, a starting dose of 150 mg lanadelumab every 2 weeks may also be considered. In patients who are stably attack free on treatment, a dose reduction to 150 mg lanadelumab every 4 weeks may be considered. Children 2 to less than 12 years of age The recommended dose of lanadelumab for children 2 to less than 12 years of age is based on body weight (see table below) and should only be administered via a pre-filled syringe or vial. The pre-filled pen has not been studied in children 2 to less than 12 years of age and therefore should not be used. |
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in
Guidance for use
TAKHZYRO treatment should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). For adults and adolescents (12 to less than 18 years of age), TAKHZYRO may be self-administered or administered by a caregiver only after training on subcutaneous injection technique by a healthcare professional. For children (2 to less than 12 years of age), TAKHZYRO should only be administered by a caregiver after training on SC subcutaneous injection technique by a healthcare professional.
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.
The most commonly observed adverse reaction (
Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (
Very common adverse reactions (frequency ≥1/10) were injection site reactions including: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.
Please consult the EMA TAKHZYRO® Summary of Product Characteristics before prescribing.1
Important Notice
For the purposes of this notice, "press release" means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefings and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction.
1 https://www.ema.europa.eu/en/medicines/human/EPAR/takhzyro. Relevant documents to be published here as soon as publicly available.
2 https://www.clinicaltrials.gov/study/NCT03918239?intr=NCT03918239&rank=1#more-information. Last accessed: February 2025.
3 Longhurst, H. J., & Bork, K. (2019). Hereditary angioedema: an update on causes, manifestations and treatment. British Journal of Hospital Medicine, 80(7), 391-398.
4 Maurer, M., et al. (2022). The international WAO/EAACI guideline for the management of hereditary angioedema—The 2021 revision and update. Allergy, 77(7), 1961–1990. https://doi.org/10.1111/all.15214.
5 Banerji, A., Davis, K. H., Brown, T. M., Hollis, K., Hunter, S. M., Long, J., ... & Devercelli, G. (2020). Patient-reported burden of hereditary angioedema: findings from a patient survey in the United States. Annals of Allergy, Asthma & Immunology, 124(6), 600-607.
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