EMA Approves New Subcutaneous Option for TAKHZYRO® in HAE Patients Aged 12+

Takeda has announced a significant advancement for the treatment of Hereditary Angioedema (HAE) with the European Medicines Agency's (EMA) approval of a new 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab). This new option is designed for subcutaneous administration in adolescents aged 12 years and above, as well as adults. It aims to offer a more customized treatment approach, enhancing the management of this life-threatening condition.

Hereditary Angioedema is a rare genetic disorder that occurs in around 1 in 50,000 people worldwide. This condition leads to repeated episodes of severe swelling in various parts of the body, which can be debilitating and painful. If the swelling affects the airways, it can become life-threatening due to potential asphyxiation. Despite its severity, HAE is often underrecognized, underdiagnosed, and undertreated, making advancements in treatment options crucial for improving patient outcomes.

The introduction of the pre-filled pen option for TAKHZYRO is a significant step forward for HAE treatment. It provides an individualized treatment plan for patients aged 12 and older, facilitating easier administration and potentially improving adherence to treatment regimens. The approval of this administration method reflects Takeda’s ongoing commitment to supporting the HAE community by offering innovative solutions and improving overall quality of life for patients.

TAKHZYRO, which contains lanadelumab, is already available in several forms, including a 150 mg solution for injection in a pre-filled syringe, a 300 mg solution for injection in a pre-filled syringe, and a 300 mg solution for injection in a vial. The new pre-filled pen contains 300 mg of lanadelumab in 2 mL of solution, further extending the range of options available to patients and healthcare providers. The approval was supported by clinical studies that highlighted the efficacy of lanadelumab in reducing the frequency of HAE attacks.

Takeda has consistently shown leadership in the field of HAE treatment, driven by a robust data pool from extensive historical research and patient engagement. The company is focused on developing innovative treatments that address the unique needs of patients with HAE and other underserved communities, aiming to enhance the overall patient experience through a patient-centric approach.

In addition to offering new treatment options, Takeda emphasizes the importance of early diagnosis and continuous management of HAE. The company is committed to advancing the science behind rare diseases and working closely with patients, families, and healthcare providers to translate insights into tangible solutions. This approach aligns with Takeda's broader mission to create life-transforming treatments and improve global health outcomes.

Furthermore, Takeda underlines the need for proper training on the administration of TAKHZYRO, particularly for caregivers and healthcare professionals. This ensures that patients receive the best possible care while minimizing the risks associated with hypersensitivity reactions, which have been observed in some cases. The most common adverse reactions associated with TAKHZYRO are injection site reactions, which are generally mild and resolve quickly.

Overall, the approval of the new pre-filled pen option for TAKHZYRO represents a significant advancement in the treatment of HAE, providing patients with more choices and potentially improving their quality of life. Takeda's ongoing dedication to innovation and patient care continues to drive progress in the treatment of this rare and challenging condition.