New treatment for HAE, called garadacimab, approved in USA for the prevention of attacks of hereditary angioedema (HAE)

Garadacimab, a new HAE treatment to prevent HAE attacks, has been approved by the US Food and Drug Administration (FDA).

The new medicine, also known as Andembry, is a once a month injection. In clinical trials it reduced HAE attacks by a median of more than 99 percent and a least squares mean of 89.2 percent, compared to placebo, according to information shared with HAEi by the pharmaceutical company CSL.

CSL confirmed that garadacimab will be launched immediately. Garadacimab is now available in the US, Australia, United Kingdom, European Union, Japan, Switzerland and the United Arab Emirates.

Bill Mezzanotte MD, Executive Vice President and Head of R&D at CSL, said: “Andembry, the first monoclonal antibody discovered and developed entirely by CSL, offers people living with this life-threatening condition long-term control over their disease along with a convenient administration method. Andembry underscores our long-standing and enduring commitment to better the lives of the patients we serve, including those suffering with HAE. I’d like to thank all the physicians, patients and my colleagues who contributed to this exciting milestone for HAE patients and CSL.”

Anthony J. Castaldo, CEO and Chairman of the Board, US HAE Association and HAE International, said: “Andembry, a novel once-monthly subcutaneous treatment that inhibits factor XIIa, is a welcome addition to the HAE treatment landscape. People with HAE now have another choice for lessening the burden associated with this lifelong condition and realizing the community’s shared goal of experiencing life to the fullest.”

(Source: CSL)