European Commission approves Takhzyro (lanadelumab) to include children with hereditary angioedema (HAE) as young as 2 years of age
The European Commission has expanded the approval of Takhzyro (lanadelumab) to include children with hereditary angioedema (HAE) as young as 2 years of age
This makes Takhzyro the first routine preventive, or prophylactic, treatment for HAE attacks to be approved for patients younger than 6 in the European Economic Area, which includes European Union countries, as well as Iceland, Liechtenstein, and Norway.
The approval comes after a positive opinion from the Committee for Medicinal Products for Human Use, an arm of the European Medicines Agency, following a similar move in the U.S. earlier this year.
HAE is a rare genetic condition marked by the excessive production of a pro-inflammatory molecule called bradykinin, resulting in recurring swelling attacks in various parts of the body, including the face, abdomen, hands, feet, genitals, and throat. Such attacks can happen very early in childhood and have the potential to block the airways, which can be life-threatening. Potentially fatal upper airway angioedema has been reported in patients as young as 3 years old, presenting an acute unmet need in some of the most vulnerable of HAE patients.
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