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European Medicines Agency Approves TAKHZYRO® for New Subcutaneous Administration Option

Overview

On February 24, 2025, the European Medicines Agency (EMA) granted approval for a new 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab), specifically designed for patients aged 12 years and older suffering from recurrent attacks of hereditary angioedema (HAE). This new administration method substantially broadens the treatment options available for adolescents and adults, allowing for a more personalized approach.

Purpose of Approval

The approval signifies a commitment by Takeda Pharma (TSE: 4502; NYSE: TAK) to enhance the quality of life for HAE patients, who frequently experience debilitating symptoms. Its primary goal is to minimize the burden of HAE while ensuring easier access to a critically needed therapy, aligning with the company’s mission of supporting those affected by this rare genetic disorder.

Importance of HAE Treatment

Hereditary angioedema is a complex condition that affects approximately 1 in 50,000 individuals globally. Characterized by recurrent swelling attacks in various body parts—such as the face, limbs, and throat—these episodes can be life-threatening, especially if they obstruct airways. Unfortunately, HAE is often under-recognized and under-treated, contributing to the ongoing struggle many patients face in managing their condition.

Irmgard Andresen, Global Medical Lead HAE at Takeda, emphasized the necessity for more individualized treatment protocols, stating, "We welcome the swift approval by the EMA on this additional subcutaneous administration option. HAE patients aged 12 and older now have an additional individualized treatment option available to them."

Details of the New Administration Option

The newly approved TAKHZYRO® pre-filled pen offers a convenient and effective option for self-administration of the medication. Previously, the drug was available exclusively via a pre-filled syringe or vial. Under the EMA's new guidelines, patients can now opt for this pre-filled pen, which contains 300 mg of lanadelumab in a 2 mL solution. This option is aimed at enhancing the management of HAE through a more user-friendly format, allowing trained patients and caregivers to administer the medication at home.

The efficacy of this new formulation is supported by clinical data, showcasing its effectiveness in reducing HAE attacks over time. Takeda is steadfast in its provision of innovative therapies and its leadership within the HAE treatment community by tailoring solutions to meet patients' unique needs.

The Science Behind TAKHZYRO®

Lanadelumab is a fully human monoclonal antibody specifically designed to target and inhibit plasma kallikrein, thereby reducing the frequency of HAE attacks. With a recommended dosage of 300 mg every two weeks, or an adjusted frequency for stable patients, this treatment option is frequently utilized in the HAE management regimen for patients aged 2 years and up.

TAKHZYRO® represents one of the largest clinical trials performed in the prevention of recurrent HAE attacks, providing a robust data set that underpins its approval and adoption.

Concluding Thoughts

The approval of the TAKHZYRO® pre-filled pen option is a significant step forward in improving the care and support available for those living with hereditary angioedema. By prioritizing individualized treatment methods, Takeda is committed to enhancing the therapeutic landscape for HAE patients, ultimately impacting their day-to-day lives positively.

This initiative also highlights the increasing recognition of rare diseases like HAE, emphasizing the need for continued research and innovation in the field. Following this notable milestone, both patients and healthcare providers can expect improved management options that resonate with their evolving treatment needs.

For more information, visit Takeda.