"Takeda announced that the EMA has approved 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.
The additional subcutaneous administration option expands Takeda’s offering in this space, showing dedication to the HAE community while providing individualized treatment options to support patients with a life-threatening disease, by helping to reduce HAE burden and improving their quality of life.
“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 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.
Takeda is dedicated to providing innovative treatment options to support patients, particularly those from underserved communities, and continues its leadership in HAE treatment, supported by a noteworthy data pool from historical engagement in this area.
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 affects an estimated 1 in 50,000 people worldwide. It is often under recognised, under diagnosed and under treated.
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. At Takeda we are a committed champion for the patients we serve. Every individual living with HAE is unique and by listening and reacting to their needs, we translate the insights we gain into innovative solutions – from diagnosis to ongoing management. Advancing the science is crucial to the way we operate and we are bold in our mission to accelerate diagnosis and develop treatments that will make a difference to the lives of HAE patients, their support networks and those medical professionals who care for them.
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.
Takeda is focused on creating better health for people and a brighter future for the world. The company aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.