Phase III SHP643-301 study of Takhzyro meets objectives in hereditary angioedema.
Takeda announced that the Phase III SHP643-301 study (NCT04070326) evaluating the safety profile and pharmacokinetics (PK) of Takhzyro (lanadelumab) in patients 2 to <12 years of age in preventing hereditary angioedema (hae) attacks is complete and has met its objectives.
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 HAE attacks as well as characterizing the pharmacodynamics of Takhzyro in pediatric subjects 2 to <12 years of age. this study is complete, and full results will be presented at upcoming medical meeting(s).
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