Takhzyro meets Phase III goals in children with HAE

Japan’s largest drugmaker Takeda (TYO: 4502) today announced that the Phase III SHP643-301 study evaluating the safety profile and pharmacokinetics (PK) of Takhzyro (lanadelumab) in patients aged two to <12 years of age 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 hereditary angioedema (HAE) attacks as well as characterizing the pharmacodynamics of Takhzyro in pediatric subjects two to <12 years of age.

Already approved in major markets, including the USA, Europe, Japan and China, Takhzyro is a fully-human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for prophylaxis to prevent HAE attacks in patients 12 years and older. The drug generated sales of around $795 million in the fiscal year ended March 2021.