Posted by Michael Wonder on 27 Feb 2018
EMA grants accelerated assessment for Shire’s lanadelumab being evaluated for the prevention of attacks in hereditary angioedema patients aged 12 years and older
27 February 2018 - Shire is on track to submit EU marketing authorisation application in the coming weeks.
Shire announced today the CHMP of the EMA has granted an accelerated assessment 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 (HAE).
The clinical development program for Shire's investigational HAE treatment includes data from four clinical trials, including HELP™, the pivotal Phase 3 efficacy and safety study, along with interim data from its extension study. HELP, the largest prevention study in HAE conducted to date, enrolled a total of 125 patients aged 12 years and over with type I/II HAE. The HELP study demonstrated that subcutaneous administration of 300 mg lanadelumab once every two weeks resulted in an 87% reduction in the mean frequency of HAE attacks.
