Shire Gains EU Approval for its Preventive Treatment of Hereditary Angioedema

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Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.

Global biotechnology company, Shire, has announced in a Nov. 30, 2018 press release, that the European Commission has granted marketing authorization for Takhzyro (lanadelumab) subcutaneous injection.

Takhzyro is a monoclonal antibody therapy administered via subcutaneous injection for the preventative treatment of hereditary angioedema (HAE) in patients aged 12 years and older. The therapy works by inhibiting the activity of plasma kallikrein-an enzyme that is uncontrolled in people suffering from HAE-and thus prevents attacks, which can be a recurring side effect of the condition, HAE.

“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,” said Andreas Busch, PhD, executive vice-president, head of research and development at Shire, in a press release. “With Takhzyro, we can now provide an innovative treatment that has potential to change the way HAE is currently treated.”

Henrik Balle Boysen, executive director for HAEi added, “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.”


The marketing authorization approval was supported with data from the Phase III Hereditary Angioedema Long-term Prophylaxis (HELP) study, which demonstrated an overall statistically significant attack rate reduction in Takhzyro treatment arm versus placebo.

Source: Shire