Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema - swelling - in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful. 2,3,4 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.2,5. HAE affects an estimated 1 in 50,000 people worldwide.2 In
This approval is primarily based on results of the global Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study and the Phase 3 HELP Study Open-label Extension (OLE), in addition to results of a Phase 3 study evaluating the efficacy and safety of TAKHZYRO in Japanese patients. Combined, these studies have demonstrated the efficacy and safety profile of TAKHZYRO as a preventive treatment for HAE attacks.1,6,7
'In addition to the burden of debilitating and potentially life-threatening HAE attacks, the unpredictable nature of this disease presents significant challenges to patients and their support networks,' said
TAKHZYRO received its first approval for the prevention of HAE attacks in patients 12 years and older in 2018 in
About the HELP Study6,7
In the randomized, double-blind, placebo-controlled HELP study, which included 125 patients with HAE, lanadelumab reduced the mean number of monthly HAE attacks by 87% relative to placebo when administered at 300 mg every two weeks and 73% relative to placebo when administered at 300 mg every four weeks (adjusted P
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