BioCentury
ARTICLE | Clinical News

Cinryze regulatory update

March 21, 2011 7:00 AM UTC

EMA's CHMP issued a positive opinion recommending approval of an MAA for Cinryze to treat acute angioedema attacks in patients with hereditary angioedema (HAE), for pre-procedure prevention of angioedema attacks in HAE patients, and for routine prevention of angioedema attacks in HAE patients with severe and recurrent attacks who are intolerant to or insufficiently protected by oral prevention treatments or inadequately managed with repeated acute treatment. CHMP also recommended labeling to allow for self-administration of the complement 1 (C1) esterase inhibitor. ...