New Subcutaneous Administration for TAKHZYRO® Approved by EMA for HAE Patients

EMA Approves New Administration Option for TAKHZYRO®

On February 24, 2025, the European Medicines Agency (EMA) granted approval for a new subcutaneous administration option of TAKHZYRO® (lanadelumab) for patients aged 12 years and older suffering from recurrent attacks of hereditary angioedema (HAE). This new option consists of a 2 mL pre-filled pen designed to simplify administration and to allow for personalized treatment approaches for adolescents and adults diagnosed with this rare condition.

Background on Hereditary Angioedema

Hereditary angioedema is a genetic disorder that can cause unpredictable bouts of severe swelling in various body parts, including the abdomen, face, extremities, and even the airway, which can lead to life-threatening complications. This condition affects approximately 1 in 50,000 individuals worldwide and often goes unnoticed, misdiagnosed, or inadequately treated.

The approval of TAKHZYRO® for the subcutaneous administration comes as a significant development in HAE management, as it complements the existing intravenous and pre-filled syringe options already available for patients. With this new delivery method, Takeda aims to support patients more effectively while addressing their unique treatment needs.

Benefits of Subcutaneous Administration

The subcutaneous option is highlighted as a way to encourage adherence to treatment regimens among HAE patients. "The efficient and convenient method of administration provided by the pre-filled pen can be critical in managing a condition that demands timely and consistent treatment. We are thrilled with EMA's prompt approval of this new option, which reflects our commitment to providing innovative treatment solutions," stated Irmgard Andresen, Global Medical Lead for HAE at Takeda.

Currently, TAKHZYRO® is approved in the EU for routine prevention of recurrent HAE attacks for patients aged 2 years and older, and the new presentation adds flexibility for adolescents and adults in their treatment plans. Unlike existing options, the pre-filled pen allows for easy self-administration or caregiver administration after appropriate training.

Indications and Administration Guidelines

TAKHZYRO® is intended for systematic prevention of recurrent HAE attacks and can be administered based on weight considerations for the pediatric segment and standardized doses for adolescents and adults. Following a physician’s advice, adults and adolescents may initiate treatment with a dose of 300 mg every two weeks, with the potential to adjust based on individual response.

Given the complexities of HAE, it's frequently challenging for patients and their providers to navigate treatment options. Takeda emphasizes the importance of individualized care and the necessity of collaboration with healthcare professionals to optimize management strategies for people living with HAE.

The Role of Takeda in HAE

Takeda has reaffirmed its dedication to understanding and addressing the specific challenges faced by the HAE community. With a broad portfolio focused on rare diseases, Takeda consistently seeks to enhance patient experiences and improve therapeutic options through scientific advancements and historical commitment in the field.

In conclusion, the EMA's approval of TAKHZYRO® as a subcutaneous administration option marks a progressive step in hereditary angioedema treatment. With its user-friendly delivery mechanism, it seeks to alleviate the burden of HAE suffering and enhance the overall quality of life for impacted patients.

For more information about TAKHZYRO® and its applications in HAE management, please visit Takeda’s official website at www.takeda.com.