BRIEF—Chugai's Hemlibra OKed for hemophilia A without inhibitors in Taiwan

Japanese drug major Chugai Pharmaceuticals today revealed that its wholly-owned Taiwanese subsidiary has  obtained approval from the Taiwan Food and Drug Administration (TFDA) for Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors administered once weekly, every two weeks, or every four weeks by subcutaneous injection.

The TFDA has also approved additional dosing options of every two weeks or every four weeks in patients with hemophilia A with factor VIII inhibitors, said Chugai, which is majority-owned by Swiss pharma giant Roche.

Hemlibra is approved in more than 90 countries, since the product has been approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors for the first time in the world by the US Food and Drug Administration in November 2017.