Takeda announces new data from ad-hoc analysis of Phase 3 HELP Study
Takeda Pharmaceutical announced new data from an ad-hoc analysis of the Phase 3 HELP Study, designed to evaluate the onset of action for TAKHZYRO during days 0-69 of treatment. The analysis suggests that TAKHZYRO starts to prevent hereditary angioedema, or HAE, attacks during this early treatment phase, with patients experiencing an 80.1% decrease in mean monthly attack rate compared to placebo. The results were presented during the European Academy of Allergy and Clinical Immunology, or EAACI, Congress in Lisbon, Portugal. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of oedema in various parts of the body. The ad-hoc analysis evaluated the efficacy of TAKHZYRO compared with placebo during days 0-69 of treatment using the same approach that was used to evaluate the primary and secondary endpoints during the complete study period. Results from the analysis showed that in patients receiving the recommended starting dose of TAKHZYRO 300 mg every two weeks, there was a significant reduction in mean monthly attack rate compared to placebo. During this initial treatment phase, patients treated with TAKHZYRO 300 mg every two weeks also experienced fewer severe attacks compared to placebo and were more likely to be HAE attack-free compared to those on placebo.