FDA approves Shire’s Takhzyro

Shire’s Takhzyro is a monoclonal antibody treatment administered every two weeks by injection, and is the first of its kind for treating the rare genetic condition hereditary angioedema, which causes swelling in the hands, face and airways. Following data from four successful clinical trials including the HELP study, the US Food & Drug Administration has approved the treatment in the US.

Andreas Busch, Ph.D., EVP, Head of Research and Development at Shire said: “With the approval of TAKHZYRO, HAE patients have an innovative treatment that works differently than current options to help prevent attacks. Based on an exploratory and post hoc analysis, after six doses of TAKHZYRO 300 mg every two weeks, 77% or nearly 8 of 10 patients had zero attacks. This approval reinforces our ongoing commitment to developing novel therapies that have a meaningful impact on patients. Looking to the future, we continue to work towards our goal of a world in which those living with HAE can aim for zero attacks.”

Anthony Castaldo, president of the US Hereditary Angioedema Association, said: “HAE attacks are painful, debilitating, and potentially life threatening. Takhzyro provides the HAE community with 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 trial program that enabled this important addition to the HAE treatment landscape.”