China’s National Medical Products Administration (NMPA) has approved Takhzyro (lanadelumab) subcutaneous injection for prophylaxis to prevent attacks of HAE in patients 12 years and older. Takhzyro from Takeda Pharmaceutical Company Limited is a fully human monoclonal antibody (mAb) that inhibits the activity of plasma kallikrein, an enzyme which is uncontrolled in people with HAE, to help prevent HAE attacks.
“The approval of Takhzyro is exciting news for the HAE community in China”, says Fiona Wardman, the Chief Regional Patient Advocate at Hereditary Angioedema International. “Until now, no modern therapies have been available to HAE patients in the country, and people with HAE rely on anabolic androgens and tranexamic acid for prophylaxis, and fresh frozen plasma for emergencies. The availability of Takhzyro to help prevent HAE attacks represents significant progress for those living with this chronic condition.”
“This milestone demonstrates Takeda’s ongoing commitment to support the HAE community globally, as we work to expand access to Takhzyro and potentially 14 more highly innovative Takeda medicines to China’s patients over the next five years,” says Sean Shan, President of Takeda China. “The Chinese government’s recent healthcare reforms play an evolving role in reaccelerating the delivery of important therapies like Takhzyro to as many patients as possible through their efforts to increasingly reward innovation.”
Takhzyro has a half-life of approximately two weeks and may be self-administered as one subcutaneous injection every two weeks, only after training by a healthcare professional. The recommended starting dose is 300 mg every two weeks. A dosing interval of 300 mg Takhzyro every four weeks is also effective and may be considered if the patient is well-controlled (e.g., attack free) for more than six months. In clinical trials, the majority of patients took within 10 to 60 seconds to administer the injection.
Takhzyro is currently available in more than 20 countries and additional regulatory submissions are ongoing worldwide.
(Source: Takeda)
