CHMP recommends approval of Centralized Marketing Authorization for Cinryze

Mar 19 2011

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 severely affected HAE patients. It is also beneficial that this C1-inhibitor therapy is also to be approved for therapy of acute attacks and pre-procedure prevention."

"This positive CHMP opinion marks a key step in making Cinryze available to HAE patients across Europe and beyond that choose to proactively address their disease," commented Thierry Darcis, M.D., ViroPharma's vice president, general manager, Europe.  "We estimate that there are several thousand patients throughout Europe who suffer from this debilitating disease, and with this recommendation, these patients may soon benefit from the unique use of Cinryze to either prevent their attacks or treat them when they occur, with the added convenience of self administration after appropriate training.  ViroPharma is committed to providing important medicines to patients with unmet medical needs, and we look forward to working closely with physicians across Europe toward this important goal."

The CHMP is the scientific advisory body of the EMA responsible for reviewing Marketing Authorization Applications for medicinal products for human use.  The CHMP positive opinion forms the scientific basis for the European Commission to issue a binding decision for a Centralized Marketing Authorization, once issued, is valid throughout all the Member States of the European Union (EU) as well as in the European Economic Area (EEA), namely Norway, Iceland and Liechtenstein. The anticipated timeframe for the European Commission decision is in the second quarter of 2011.  A summary of the CHMP opinion will be available here: http://tinyurl.com/2am4ubc.  Please select "C" to access the Cinryze summary opinion.

Continued Darcis, "Our work is already well underway towards preparing for our commercial launch in Europe, with the goal of making this important therapeutic product available to European patients as soon as possible."

Cinryze was designated an orphan medicinal product on October 8, 2009. Upon granting of a Centralized Marketing Authorization and retention of the orphan medicinal product designation, Cinryze would be entitled to a period of 10 years market exclusivity in respect of the approved therapeutic indication. This 10-year market exclusivity period could be extended cumulatively to 12 years when the results of all studies conducted in compliance with an agreed pediatric investigation plan are completed and included in the summary of product characteristics.