Takeda gets EMA nod for additional subcutaneous administration of Takhzyro in Hereditary Angioedema patients
Zurich: Takeda has announced that the European Medicines Agency (EMA) has given approval for an additional 2 mL pre-filled pen option for TAKHZYRO ((lanadelumab) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with Hereditary Angioedema (HAE).
"HAE affects an estimated 1 in 50,000 people worldwide and is often under recognised, under diagnosed and under treated. We welcome the swift approval by the EMA on this additional subcutaneous administration option," said Irmgard Andresen, Global Medical Lead HAE at Takeda. "HAE patients 12 years and older now have an additional individualized treatment option available to them."
TAKHZYRO (lanadelumab) is currently approved as 150 mg solution for injection in pre-filled syringe, 300 mg solution for injection in pre-filled syringe, and 300 mg solution for injection in vial. This approval for an additional subcutaneous administration option, TAKHZYRO 300 mg solution for injection in pre-filled pen, containing 300 mg of lanadelumab in 2 mL of solution, was supported by a clinical study.
Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful. Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.
HAE, like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need.
Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for routine prevention of recurrent attacks of HAE in patients aged 2 years and older. It was studied in one of the largest prevention studies in HAE with the longest active treatment duration, and Lanadelumab consistently demonstrated HAE attack reduction. Lanadelumab is formulated for subcutaneous administration and has a half-life of approximately two weeks. Lanadelumab is intended for self-administration or administration by a caregiver once trained by a healthcare professional.
