Shire has announced that the European Commission has approved its hereditary angioedema (HAE) drug Takhzyro.
Takhzyro (lanadelumab) is a subcutaneous injection indicated for routine prevention of recurrent HAE attacks in patients aged 12 years and older.
The drug is a first of its kind fully human monoclonal antibody (mAb), that inhibits the activity of plasma kallikrein, an enzyme which is uncontrolled in people with HAE, to help prevent attacks.
Approval was supported by the Phase III HELP study, which found that Takhzyro cut the mean number of monthly HAE attacks by 87% relative to placebo, when administered at 300mg every two weeks, and 73% relative to placebo when administered at 300mg every four weeks.
Findings also showed that over the entire 26-week study, 44% of patients taking Takhzyro 300mg every two weeks were attack free versus 2% of those taking a placebo.
Henrik Balle Boysen, executive director for HAEi, welcomed the decision, noting that it “provides a new option for the prevention of HAE attacks.
“We are grateful for the time and effort put forth by the patients and researchers who participated in the clinical program that enabled this important addition to the HAE treatment landscape.”
“With Takhzyro, we can now provide an innovative treatment that has potential to change the way HAE is currently treated,” noted Andreas Busch, executive vice president, head of Research and Development, at Shire.
