TAKHZYRO® (lanadelumab) Open Label Phase 3 Study Met its Objectives in Children Ages 2 to <12 Years of Age with Hereditary Angioedema (HAE)

发布时间： 2022-04-29 阅读：483次

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Apr. 20, 2022-Takeda today announced that the Phase 3 SHP643-301 study evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives.

SHP643-301 is A Multicenter, Open-Label Phase 3 Study to Evaluate Safety, PK, Pharmacodynamics, And Clinical Activity/Outcomes of TAKHZYRO for Prevention Against Acute Attacks of HAE in Pediatric Patients 2 To <12 Years of Age. Participants aged 2 to < 6 years received lanadelumab at a dose of 150 milligrams (mg) every 4 weeks (q4wks) over 52-week treatment period. Participants aged 6 to <12 years received lanadelumab at a dose of 150 mg every 2 weeks (q2wks) over 52-week treatment period. 

This study is complete. The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older; there were no serious adverse events and no dropouts due to adverse events. The study also successfully reached the secondary objective evaluating the clinical activity/outcome of TAKHZYRO in preventing hereditary angioedema (HAE) attacks as well as characterizing the pharmacodynamics of TAKHZYRO in pediatric subjects 2 to <12 years of age.