Japan-headquartered Takeda (NYSE: TAK, TYO: 4502) announced that the European Medicines Agency (EMA) has approved a label extension for Takhzyro (lanadelumab) for subcutaneous administration in adolescents aged 12 and above and adult patients with Hereditary Angioedema (HAE) using a 2 mL pre-filled pen.
Drug Profile
Takhzyro is now approved in the following forms:
- 150 mg solution for injection in pre-filled syringe
- 300 mg solution for injection in pre-filled syringe
- 300 mg solution for injection in vial
- Newly approved: 300 mg solution for injection in pre-filled pen (300 mg in 2 mL)
Lanadelumab, a fully human monoclonal antibody, binds and reduces plasma kallikrein, preventing recurrent HAE attacks in patients aged 2 and older. The drug was studied in one of the largest HAE prevention trials with the longest active treatment duration, consistently reducing HAE attacks. It has a half-life of approximately two weeks and is administered subcutaneously.-Fineline Info & Tech
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