Takeda has received approval from the Ministry of Health, Labour and Welfare (MHLW) for TAKHZYRO® (lanadelumab) subcutaneous injection 300mg syringes for prophylaxis against acute attacks of HAE in adult and pediatric patients 12 years of age and older in Japan.
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.
“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,” says Naoyoshi Hirota, General Manager, Takeda Development Center, Japan. “We hope TAKHZYRO, a new treatment option for patients in Japan living with HAE, along with the efficacy and safety profile as a preventive treatment showcased across global studies and within a Japan-specific Phase 3 study, will contribute to HAE treatment.”
TAKHZYRO received its first approval for the prevention of HAE attacks in patients 12 years and older in 2018 in the United States and in the European Union and is now approved in more than 50 countries. TAKHZYRO is intended for self-administration or administration by a caregiver once trained by a healthcare professional. TAKHZYRO is supported by a robust clinical development program, which includes one of the largest prevention studies in HAE with the longest active treatment duration with additional regulatory submissions ongoing worldwide.
(Source: Takeda)
