ViroPharma Incorporated announced the US Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The US FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.
"We and our partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible," said Vincent Milano, ViroPharma's president and chief executive officer. "And, we plan to commence manufacturing industrial scale lots at risk in the first quarter of 2011."
Continued Milano, "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."
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by US FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.
ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing innovative products for physician specialists to enable the support of patients with serious diseases for which there is an unmet medical need, and providing rewarding careers to employees.