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Shire's Takhzyro scores EU approval in rare genetic disorder hereditary angioedema

Published on 03/12/18 at 03:44pm

Shire has announced that it has secured European approval for its subcutaneous injection Takhzyro (lanadelumab) for the routine prevention of attacks as a result of hereditary angioedema (HAE), a rare genetic disorder which can cause swelling around the body, potentially threatening a patient’s life.

Supporting the approval decision was Phase 3 data showing that Takhzyro demonstrated “statistically significant attack rate reductions”; compared to placebo, patients receiving 300mg of Takhzyro every two weeks experienced 84% fewer moderate to severe attacks, 87% fewer attacks requiring on-demand treatment, and an 89% reduction in attacks from day 14 to day 182. 44% of Takhzyro remained attack-free throughout the entire 26-week trial period, compared to just 2% in the placebo group.

“On behalf of the HAE community, we welcome today’s news that provides a new option for the prevention of HAE attacks,” commented Henrik Balle Boysen, Executive Director for HAEi, an international umbrella organisation for HAE patient groups around the world. “We are grateful for the time and effort put forth by the patients and researchers who participated in the clinical programme that enabled this important addition to the HAE treatment landscape.”

A post-hoc sensitivity analysis also illustrated that 81% of patients receiving the drug experienced a clinically meaningful improvement in quality of life, compared to 37% of placebo patients.

“We are delighted to receive today’s European approval. For those with HAE, the burden of disease can significantly impact their day to day life,” remarked Dr Andreas Busch, Executive Vice President, Head of Research and Development at Shire, “With Takhzyro, we can now provide an innovative treatment that has potential to change the way HAE is currently treated.”

Matt Fellows

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