Regulators in Europe have given the thumbs-up to ViroPharma's Cinryze for hereditary angioedema, a rare, life-threatening genetic disorder.
The European Commission has approved Cinryze (C1 inhibitor [human]) for the prevention and treatment of angioedema attacks in adults and adolescents with HAE. The approval also includes a self-administration option for "appropriately trained patients".
HAE affects at least 10,000 people in Europe and is a disease caused by a deficiency of C1 inhibitor, a human plasma protein that prevents swelling. Patients can experience attacks of swelling that can affect the larynx, abdomen, face, extremities and genitourinary tract.
ViroPharma quoted Konrad Bork of the Johannes Gutenberg University in Mainz in Germany as saying that many patients experience frequent or severe attacks "that are not only disabling and potentially fatal, but also lead to constant anxiety about when an attack will occur significantly impacting patients’ ability to conduct normal and productive lives". He added that the approval of Cinryze in Europe (it is already available in the USA) "provides a very important new option to meet the needs of these severely afflicted HAE patients.”