Posted by Michael Wonder on 24 Feb 2018
FDA accepts Shire’s biologics license application and grants priority review for lanadelumab for the prevention of attacks in hereditary angioedema patients
23 February 2018 - Lanadelumab, the first long-acting investigational monoclonal antibody in hereditary angioedema, is being evaluated for the prevention of angioedema attacks in patients 12 years and older.
Shire today announced the U.S. FDA accepted the biologics license application and granted priority review for lanadelumab (SHP643). Lanadelumab is an investigational treatment being evaluated for the prevention of angioedema attacks in patients 12 years and older with the rare, genetic disorder, hereditary angioedema.
The application for Shire's investigational treatment is supported by data from four clinical trials, including HELP, the pivotal Phase 3 efficacy and safety study, along with interim data from its extension study. HELP is the largest prevention study in hereditary angioedema (HAE) conducted to date, and enrolled a total of 125 patients aged 12 years and over with type I/II HAE.
