Posted by Michael Wonder on 29 Mar 2018
Shire reports regulatory milestones for investigational hereditary angioedema treatment lanadelumab
29 March 2018 - Filings are supported by data from HELP, the pivotal Phase 3 efficacy and safety study.
Shire announced today the EMA has validated its marketing authorisation application for lanadelumab (SHP643) and also reports that Health Canada has completed screening and accepted the new drug submission under priority review for this investigational compound.
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 estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide.
