Takhzyro (lanadelumab) is a subcutaneous injection for routine prevention of recurrent hereditary angioedema attacks in patients aged 12 years and older. It is a fully human monoclonal antibody that inhibits the activity of plasma kallikrein. The European Commission has approved Shire’s drug on the back of the Phase III HELP study which found that when patients were administered with 300mg of Takhzyro every two weeks, the mean number of monthly HAE attacks fell by 87% versus placebo. The same dose administered every four weeks reduced attacks by 73% versus placebo. Over the 26 week period of the study, of those patients on 300mg every two weeks, 44% were attack free versus 2% for placebo.
Andreas Busch, Ph.D., EVP, Head of Research and Development at Shire, said: “We are delighted to receive today’s European approval. For those with HAE, the burden of disease can significantly impact their day to day life. With TAKHZYRO, we can now provide an innovative treatment that has potential to change the way HAE is currently treated.”
“EC approves Shire’s Takhzyro“
Executive director for HAEi, Henrik Balle Boysen, said: “It provides a new option for the prevention of HAE attacks. We are grateful for the time and effort put forth by the patients and researchers who participated in the clinical program that enabled this important addition to the HAE treatment landscape. “