Shire’s angioedema drug clears regulatory hurdles in Europe and Canada

Shire's anti-angioedema drug lanadelumab has reached two regulatory milestones after being accepted for review by both the European Medicines Agency (EMA) and Health Canada.

Designed to combat attacks caused by hereditary angioedema (HAE), a rare genetic condition that causes painful, debilitating and often life-threatening swelling in the body, lanadelumab is a monoclonal antibody that acts by binding and inhibiting plasma kallikrein, a key agent in causing episodes.

The HELP clinical trial programme has indicated that the use of the drug can reduce the frequency of episodes by as much as 87 percent.

Professor Marcus Maurer of the Universitatsmedizin Berlin, Germany, one of the clinical trial investigators to have studied the treatment, said: "As a physician treating patients with HAE, I would welcome new treatment options to help prevent attacks, as it is important to recognize the impact HAE can have on the quality of life of these individuals."

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