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)

Core Insights - Takeda has received EMA approval for a new 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) aimed at adolescents (aged 12 and above) and adult patients with Hereditary Angioedema (HAE) [1][5] - This new option enhances Takeda's commitment to the HAE community by providing individualized treatment solutions to alleviate the burden of HAE and improve patients' quality of life [1][2] Company Overview - Takeda is a leading biopharmaceutical company focused on creating better health outcomes and delivering life-transforming treatments across various therapeutic areas, including rare diseases [7] - The company emphasizes innovation and patient-centric solutions, particularly for underserved communities, and has a strong historical engagement in HAE treatment [2][7] Product Information - TAKHZYRO® is a fully human monoclonal antibody that targets plasma kallikrein, indicated for the routine prevention of recurrent HAE attacks in patients aged 2 years and older [4][6] - The newly approved 300 mg solution for injection in a pre-filled pen is designed for subcutaneous administration, allowing for self-administration or caregiver administration after proper training [4][8] Market Context - HAE is a rare genetic disorder affecting approximately 1 in 50,000 people globally, often under-recognized and under-treated [2][3] - The approval of the new administration option is expected to provide additional individualized treatment choices for HAE patients aged 12 years and older, addressing a significant unmet need in the market [2][5]