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news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to ViroPharma in relation to the industrial scale manufacturing expansion activities of Cinryze (C1 Esterase Inhibitor [Human]).
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In the CRL, the FDA has asked for additional information related to observations from the pre-approval inspection and review of the technical processes.
The company claims that Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).
ViroPharma president and CEO Vincent Milano said that the company and its partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible, and they plan to commence manufacturing industrial scale lots at risk in the first quarter of 2011.
"We remain committed to provide patients with an uninterrupted supply of Cinryze. In addition to our efforts around our industrial scale, we expect our currently approved manufacturing process alone will yield up to 60,000 doses annually," Milano said.