ViroPharma gets FDA nod for Cinryze plant expansion at last
This article was originally published in Scrip
ViroPharma has secured US FDA approval for expanded manufacturing of Cinryze (human C1 esterase inhibitor), under a supplement to its BLA for industrial scale manufacturing changes. The firm had previously had two knockbacks from the agency in the form of complete response letters in 2010 and earlier this year (scripintelligence.com, 8 February 2012). The manufacturing expansion at a site in the Netherlands is needed to meet rising US demand for the product, and will enable it to "to ensure the market is fully served and build adequate safety stock levels", said COO Dan Soland. The added industrial scale process will also give it the flexibility to increase production further still through additional shifts if necessary, he noted. Cinryze has been available in the US for the prevention of angioedema attacks in patients with hereditary angioedema since 2008. In Europe it was approved last year for a broader treatment and prevention indication. Production for the European market is located at a separate site.
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