European Medicines Agency Approves New Delivery Option for TAKHZYRO® to Aid HAE Patients Over 12

Takeda Enhances Delivery Options for TAKHZYRO®



In a significant move to improve patient care, the European Medicines Agency (EMA) has granted approval for a new 2 mL pre-filled pen for TAKHZYRO® (lanadelumab), specifically targeting adolescents aged 12 and older suffering from recurrent attacks of hereditary angioedema (HAE). This new delivery system is designed to facilitate subcutaneous administration, thereby enhancing convenience and individualized treatment approaches for patients.

Understanding Hereditary Angioedema


Hereditary angioedema is a rare genetic disorder characterized by episodes of severe swelling in various body parts, including the abdomen, face, hands, feet, and throat. These episodes can be debilitating and, in severe cases, life-threatening, especially when they obstruct the airways. The condition affects approximately 1 in 50,000 individuals worldwide, often going unrecognized or misdiagnosed, leading to inadequate treatment.

HAE can impose significant restrictions on patients’ quality of life, necessitating effective management strategies. The introduction of the TAKHZYRO® pre-filled pen not only offers ease of use but aims to reduce the overall burden of the disease on patients and their families.

New Treatment Options


Previously, TAKHZYRO® was available as a solution for injection in pre-filled syringes and vials with dosages of 150 mg and 300 mg. The recent EMA approval adds to this array by allowing for the administration of 300 mg in a pre-filled pen format, making it easier for individuals to self-administer their treatment under proper supervision. This flexibility in dosage and method of administration signifies a leap forward in patient empowerment in managing HAE.

Irmgard Andresen, Global Medical Lead for HAE at Takeda, emphasized the importance of this approval: "We welcome the swift action taken by the EMA, which now provides HAE patients, 12 years and older, with an additional individualized treatment option," said Andresen. This change is indicative of Takeda's commitment to enhancing the lives of those diagnosed with this challenging condition.

Launching into Clinical Practice


The approval has been supported by clinical studies demonstrating the efficacy of lanadelumab in reducing HAE attacks, enabling patients to achieve better health outcomes. Healthcare professionals are encouraged to supervise the initial administration of TAKHZYRO® to ensure that patients and caregivers receive adequate training in the injection technique.

...Given the complex nature of HAE, comprehensive education about this condition and its management is crucial for both patients and healthcare providers. By offering versatile treatment options and prioritizing patient education, Takeda aims to bridge the gap in awareness and effective treatment strategies.

As the approved dosing regimens highlight, adult and adolescent patients who remain attack-free on treatment may consider dose reductions, which could provide further economic benefits and ease of management.

Takeda's Commitment to Rare Disease Research


Takeda is dedicated to creating innovative solutions for patients with rare diseases. Through ongoing research and engagement with the HAE community, the company strives to enhance understanding and treatment of this disorder. The extensive data gathered from their historical involvement in HAE supports their leadership in this therapeutic area. Takeda emphasizes its role as a champion for patients, ensuring that individual needs are heard and addressed through tailored solutions.

Takeda is a values-driven, research-focused biopharmaceutical company headquartered in Japan, committed to advancing healthcare globally. Patients and healthcare providers can look forward to more innovative treatments as Takeda continues to expand its portfolio and invest in research that directly impacts patient care.

For further information regarding TAKHZYRO® and its new administration methods, healthcare professionals can refer to the detailed guidance provided by the EMA and pharmacological studies that support its use and effectiveness in combating hereditary angioedema.

Topics Health)

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