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Shire's rare disease treatment granted EMA accelerated assessment

Dublin-based Shire plc said the European Medicines Agency's Committee for Medicinal Products for Human Use granted accelerated assessment to SHP643, an experimental treatment of hereditary angioedema in patients aged 12 years and above.

Hereditary angioedema is a rare, genetic disorder that causes swelling in various parts of the body, including hands, feet, face and throat. According to the U.S. Hereditary Angioedema Association, the disorder affects one in 10,000 to 50,000 people.

The accelerated assessment lowers the evaluation period to 150 days from 210. Shire said it will submit a marketing authorization application for the drug in the coming weeks.

SHP643, or lanadelumab, previously received a priority review status from the U.S. Food and Drug Administration.