Posted by Michael Wonder on 24 Aug 2018
Shire announces FDA approval of Takhyzro (lanadelumab-flyo), a first-of-its-kind mAb preventive treatment for hereditary angioedema
23 August 2018 - Takhyzro is a subcutaneous injection that took the majority of patients one minute or less to self-administer.
Shire today announced that following priority review, the U.S. FDA has approved Takhyzro (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of oedema (swelling) in various parts of the body.
In the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study supporting FDA approval, Takhyzro reduced the number of monthly HAE attacks an average of 87% (n=27) vs. placebo (n=41) when administered at 300 mg every two weeks and 73% (n=29) vs placebo (n=41) when administered at 300 mg every four weeks (Adjusted P<0.001).
