Shire: EMA Validates Marketing Authorization Application For Lanadelumab

(RTTNews) - Shire plc (SHP.L, SHPG) announced the European Medicines Agency has validated its marketing authorization application for lanadelumab. The EMA MAA validation confirms the submission for lanadelumab is sufficiently complete and an accelerated assessment for the potential therapy will begin. Lanadelumab is an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema, a rare, genetic disorder.

The company also reported that Health Canada has completed screening and accepted the New Drug Submission under Priority Review for lanadelumab. The acceptance of the lanadelumab NDS for Priority Review shortens the review timeline from 300 to 180 days.

The company noted that lanadelumab has received priority review from the U.S. FDA and is expected to provide a decision by August 26, 2018, based on the Prescription Drug User Fee Act V action date. Lanadelumab has also received priority review and orphan drug designation from the Therapeutic Goods Administration in Australia.