China approves Takeda’s Takhzyro to prevent hereditary angioedema attacks in patients over 12
pharmafile | December 8, 2020 | News story | Manufacturing and Production, Sales and Marketing | China, Takeda
China’s National Medical Products Administration (NMPA) has given approval in the country for Takeda’s Takhzyro (lanadelumab), in a subcutaneous injection formulation, for the prevention of attacks of hereditary angioedema (HAE) in patients at least 12 years old.
The decision was based on an analysis of Phase 3 data drawn from 125 HAE patients. Those receiving a 300mg injection of Takhzyro every two weeks saw the average frequency of HAE attacks reduced by 87% compared to placebo. In patients receiving the therapy every four weeks instead, this reduction stood at 73%.
Over the full 26 weeks of the study, it was found that 44% of the two-week Takhzyro group did not experience any attacks, whereas just 2% of patients in the placebo group could say the same.
With a prevalence of around one in every 50,000 patients, HAE is a rare genetic condition characterised by attacks of painful or debilitating oedema (swelling) of the face, abdomen, throat, genitals, hand and feet and other parts of the body which can be life-threatening. These attacks are triggered by the uncontrolled activity of the plasma kallikrein in HAE patients – a target which is inhibited by Takhzyro.
“The approval of Takhzyro is exciting news for the HAE community in China,” said Fiona Wardman, the Chief Regional Patient Advocate at Hereditary Angioedema International. “HAE is a severe, potentially fatal genetic condition that causes unpredictable, painful, and debilitating swelling attacks. 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.”
Sean Shan, President of Takeda China, added: “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.”
Matt Fellows
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