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Home Industry News Shire’s new HAE therapy receives EU accelerated assessment status

Shire’s new HAE therapy receives EU accelerated assessment status

28th February 2018

Shire has announced that its new drug lanadelumab has been granted accelerated assessment status by the European Medicines Agency.

The agency's Committee for Medicinal Products for Human Use (CHMP) has elected to reduce the standard 210-day review period for the drug to 150 days, reflecting the major interest it offers in terms of public health and therapeutic innovation.

Lanadelumab is an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema (HAE), a rare genetic disorder that results in swelling in various parts of the body.

The clinical development programme for the investigational HAE treatment includes data from four clinical trials, including the pivotal phase III study HELP, which has shown that lanadelumab can deliver significant reductions in the frequency of HAE attacks.

Dr Andreas Busch, executive vice-president and head of research and development at Shire, said: "We look forward to further progressing lanadelumab through the regulatory review process, as we strive to bring new and innovative solutions to the patients who need them most."

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