Posted by Michael Wonder on 21 Sep 2018
Health Canada has authorised Takhyzro (lanadelumab injection), a first-of-its-kind monoclonal antibody treatment for the prevention of hereditary angioedema attacks
20 September 2018 - New treatment option for HAE receives first international marketing authorization outside of the U.S.
Shire and Shire Pharma Canada announced today that following priority review, Health Canada has authorized Takhyzro (lanadelumab injection) for routine prevention of attacks of hereditary angioedema (HAE) in adolescents and adults (12 years of age and older).
Health Canada’s authorisation of Takhyzro for the routine prevention of HAE attacks in adolescents and adults is supported by results of the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study, in which the primary efficacy endpoint was the number of investigator-confirmed HAE attacks during the 26-week study duration.
