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.
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