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CompileDraven
On March 28, the Japanese Ministry of Health approved Takeda Takhzyro (lanadelumab) 300mg subcutaneous injection as a preventive treatment drug for Japanese patients over 12 years old with hereditary angioedema (HAE)
The approval is based primarily on the global Phase 3 HELP Study, the Phase 3 HEL Open-Label Extension (OLE) study, and a Phase 3 clinical trial in Japanese patients
The HELP Study and HELP OLE are the largest randomized controlled clinical prevention studies conducted in HAE to date, involving 125 patients with HAE
In the phase 3 study conducted in Japan, 41.
Takhzyro was originally developed by Shire, which Takeda acquired in May 2018 for $62 billion for Shire
It is reported that Takhzyro was approved by the United States and the European Union in August and November 2018, and has been approved in more than 50 countries so far
In terms of drug mechanism, the half-life of Takhzyro in HAE patients is 14 days.
Reference source: Takeda's Takhzyro® (lanadelumab) Approved in Japan for Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)
