European Commission approves label update for lanadelumab, for a broader group of pediatric patients with recurrent attacks of hereditary angioedema (HAE)
Takeda today announced the European Commission has approved Takhzyro (lanadelumab) for the routine prevention of recurrent attacks of Hereditary Angioedema (HAE) in patients aged 2 years and older, expanding its initial approved use and making it the first long-term prophylactic treatment of HAE available in European Economic Area for patients under the age of six.
The recently approved extension of the indication in pediatric patients was paired with an additional strength of 150 mg for lanadelumab solution for injection in pre-filled syringe. TAKHZYRO® 150mg should be used in patients aged 2 years and older and weighing less than 40 kg to prevent angioedema attacks in patients with Hereditary Angioedema (HAE).
“Potentially fatal upper airway angioedema has been reported in patients as young as three years old5, presenting an acute unmet need in some of the most vulnerable of HAE patients.” said Didier Relin, Head of International Regulatory at Takeda. “With this expanded label, Takhzyro offers a welcomed new preventative treatment option for the pediatric HAE patient population, and one that can be administered at home with the support of a trained caregiver.”
(Source: Takeda)
