ViroPharma Announces Positive CHMP Opinion for CinryzeÃ‚® (C1 Inhibitor Human) in European Union
EXTON, Pa., March 18, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion at its plenary meeting in March 2011 recommending approval of a Centralized Marketing Authorization for Cinryze® (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema (HAE) for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks. The recommendation includes a self administration option for appropriately trained patients included in the proposed Summary of Product Characteristics.
Specifically, the CHMP-recommended the approved therapeutic indication to include treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment. The CHMP also notes the relationship between Sanquin and ViroPharma, and that Sanquin's C1 inhibitor, Cetor, is approved in a limited number of member states for acute treatment which is one of the three indications recommended for Cinryze, as an outstanding issue that must be considered by the European Commission prior to approval of the Cinryze Marketing Authorization Application.
"This would be the first C1-inhibitor therapy to be approved in Europe for prevention of HAE attacks in patients with hereditary angioedema," commented Dr. Emel Aygoren-Pursun, Universitatsklinik (University Hospital), Frankfurt. "Prophylactic therapy with C1-inhibitor concentrate is an important step forward in the management of se