Posted by Michael Wonder on 04 Feb 2023
US FDA approves Takeda’s Takhyzro (lanadelumab-flyo) to prevent hereditary angioedema attacks in children 2 years of age and older
3 February 2023 - Approval supported by extrapolation of efficacy data from the Phase 3 HELP study with additional data from the Phase 3 SPRING study in paediatric patients 2 to <12 years of age.
Takeda today announced that the US FDA has approved the supplemental biologics license application for the expanded use of Takhyzro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema in paediatric patients 2 to <12 years of age.
