EMA Approves New Takhzyro Option
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. (NCT03918239)
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