The European Medicines Agency (EMA) has approved an additional 2 mL pre-filled pen option for subcutaneous administration of Takeda’s Takhzyro (lanadelumab), aimed at treating hereditary angioedema (HAE).
The approval is intended for adults and adolescents aged 12 years and above.
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It marks an expansion in the company’s portfolio for subcutaneous administration methods.
Takhzyro has secured approval for 150 mg of solution for injection in a pre-filled syringe, 300 mg of solution for injection in a pre-filled syringe and 300mg of solution for injection in a vial.
The latest approval for further subcutaneous administration option, 300mg solution for injection in a pre-filled pen, featuring 300mg of lanadelumab in 2 mL of solution, was backed by a clinical study.
In the European Union, the therapy has been approved for the routine prevention of recurrent HAE attacks in individuals aged two years and above.
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By GlobalDataTakeda HAE global medical lead Irmgard Andresen stated: “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.
“HAE patients 12 years and older now have an additional individualised treatment option available to them.”
Characterised by recurrent episodes of swelling in various body parts, HAE is a rare genetic condition that can be painful and, in severe cases, life-threatening. These attacks can hinder the airways, leading to asphyxiation.
A fully human monoclonal antibody, lanadelumab targets and reduces plasma kallikrein. It has been part of one of the largest HAE prevention studies with the longest active treatment time.
It showed consistent attack minimisation and has a half-life of around two weeks.
The therapy is designed for self-administration or administration by a properly trained caregiver.
Before this development, the company announced the appointment of Julie Kim as CEO, effective from June 2026.
