Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for lanadelumab (SHP643) and also reports that Health Canada has completed screening and accepted the New Drug Submission (NDS) under Priority Review for this investigational compound.
US regulators are undertaking a speedy review of Shire’s lanadelumab (SHP643) for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema (HAE).
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