Shire got the good news from the European Commission (EC) for Marketing Authorisation for Takhzyro injection, for prevention of recurrent attacks of hereditary angioedema (HAE) for teens and older patients.
Takhzyro inhibits the activity of an enzyme which is uncontrolled in people with HAE, to help prevent attacks, a potentially deadly genetic disorder that can result in recurrent attacks of swelling in different parts of the body.
In patients who are stably attack free on treatment, a dose reduction of 300 mg lanadelumab every four weeks may be considered, especially in patients with low weight, the company said.
The grant was given after the Phase III study, in which the injection reduced the mean number of monthly HAE attacks by large margin compared to placebo.
As Shire noted, the reduction was 87% when given at 300 mg every two weeks and 73% compared to palcebo when administered at 300 mg every four weeks.
Henrik Balle Boysen, Executive Director for HAEi said, “On behalf of the HAE community, we welcome today’s news that 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.”
Takhzyro also received approval for the prevention of HAE attacks in people 12 years of age and older in the U.S. in August 2018 and Canada in September 2018.