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Shire's angioedema treatment fast-tracked in EU and Canada
Shire has gained approval from the EU and Canada for accelerated assessments of its lanadelumab treatment for hereditary angioedema (HAE).
The European Medicines Agency has validated Shire's marketing authorisation application for lanadelumab and Health Canada has accepted a new drug submission under priority review for the treatment.
The EMA's validation means an accelerated assessment for the potential therapy can begin after the number of evaluation days required was reduced from 210 to 150 in January. Health Canada's acceptance of the treatment for priority review shortens the timeline from 300 days to 180 days.
HAE is a rare, genetic disorder that causes debilitating, painful and sometimes life-threatening swelling in the body. Lanadelumab is an antibody Shire is seeking to develop for the prevention of angioedema attacks in patients aged 12 and older with the HAE.
Shire, which this week has been subject of bid interest from Japan's Takeda Pharmaceutical, said lanadelumab's progress reinforced its leadership in rare disease treatments. Lanadelumab has also been given priority review status in the US and Australia.
Andreas Busch, Shire's head of research and development said: "HAE presents a significant burden on the lives of patients whose recurring attacks of swelling can be debilitating and painful. 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. We look forward to working with regulatory bodies to bring a new treatment option to HAE patients."