"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."
|SOURCE ViroPharma Incorporated|
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