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
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