Pharma Focus Asia

U.S. FDA Approves Takeda’s TAKHZYRO® (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) Attacks

Saturday, February 04, 2023

Takeda announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics Licence Application (sBLA) for the expanded use of TAKHZYRO® (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in paediatric patients 2 to <12 years of age. Before today’s approval, the only approved routine prophylaxis treatment options for children 6 to <12 years of age required dosing every three to four days, and children with HAE 2 to <6 years of age had no approved prophylaxis treatment, making TAKHZYRO the first prophylaxis treatment for this age group.1-5 The recommended dose is 150 mg/1 mL solution in a single-dose prefilled syringe every four weeks in patients 2 to <6 years of age and every two weeks in patients 6 to <12 years of age.

TAKHZYRO is the first and only prophylaxis treatment approved in the U.S. for Children 2 to <6 years of age with HAE1-4. This approval of the expanded indication of TAKHZYRO represents a significant step forward for the HAE community helping some of the youngest patients living with the disease to have a long-term prophylaxis treatment available.

Hereditary Angioedema (HAE) is a rare, debilitating and potentially life-threatening condition that causes unpredictable and serious angioedema attacks that occurs early in childhood.

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