China’s Drug Regulator Approves Hereditary Angioedema Treatment From Takeda

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.