Shire's investigational HAE treatment lanadelumab accepted for review by regulators in EU, Canada

Shire announced Thursday that the European Medicines Agency has determined there is sufficient data to begin an accelerated assessment of its marketing application for the plasma kallikrein inhibitor lanadelumab. Shire noted that the experimental therapy, formerly known as SHP643, which is being evaluated for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema (HAE), has also been accepted for priority review by Health Canada. 

According to the company, the submissions are supported by data from four clinical studies, including the Phase III HELP trial, along with interim data from its extension study. Top-line results from the 125-patient HELP trial unveiled last May showed that subcutaneous administration of a 300-mg dose of lanadelumab once every two weeks led to an 87-percent reduction in the mean frequency of investigator-confirmed HAE attacks versus placebo. Shire also noted that no treatment-related serious adverse events or deaths were reported.

Andreas Busch, head of R&D at the company, said "lanadelumab is the first monoclonal antibody under evaluation to prevent HAE attacks and has the potential to change the treatment paradigm for this rare disease, if approved."

Earlier this year, the FDA granted priority review to Shire's lanadelumab submission for the prevention of angioedema attacks in HAE patients aged 12 years and older, with a final decision expected by August 26. Shire also said lanadelumab has been given priority review and an orphan drug designation by Australia's Therapeutic Goods Administration. 

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