Shire study shows benefits of hereditary angioedema therapy

Shire has announced the findings of a new clinical study that demonstrates the safety and efficacy of a new treatment for hereditary angioedema.

Topline phase III results from the global HELP study highlighted the improvements associated with subcutaneously administered lanadelumab versus placebo over 26 weeks in hereditary angioedema patients aged 12 years or older.

The primary endpoint and all secondary endpoints of the trial were met after lanadelumab was shown to be associated with highly statistically significant and clinically meaningful results across all three treatment arms compared to placebo. The 300 mg dose, administered once every two weeks, resulted in an 87 percent fall in attack frequency.

Hereditary angioedema is a rare genetic disease characterised by recurrent swelling of the extremities, gastrointestinal tract and upper airways. It can be debilitating, painful and potentially life-threatening, due to the risk of asphyxiation.

Dr Flemming Ornskov, Shire's chief executive officer, said: "We have nearly a decade of experience and a strong portfolio and pipeline in hereditary angioedema and believe this data demonstrates high potential for transforming the way patients living with this condition are treated."

These findings will support future regulatory filings for the drug in the US, Europe and elsewhere.

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