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Home » China’s Drug Regulator Approves Hereditary Angioedema Treatment From Takeda
China’s Drug Regulator Approves Hereditary Angioedema Treatment From Takeda
December 10, 2020
Japan’s Takeda has received approval from China’s drug regulatory agency for Takhzyro (lanadelumab), a subcutaneous injection meant to prevent hereditary angioedema (HAE) attacks in patients who are at least 12 years old.
The monoclonal antibody works by blocking the activity of a certain enzyme, plasma kallikrein, which is uncontrollable in HAE sufferers and causes attacks.
Approval was supported by a phase 3 study enrolling 125 HAE patients, with attacks reduced by 87 percent vs. placebo when administered biweekly at a 300-mg dosage.
The drug is approved in more than 20 countries. A rare genetic disorder, HAE afflicts approximately 1 in 50,000 people globally.
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