ViroPharma Incorporated announced that the U.S Food and Drug Administration (FDA) issued a complete response letter regarding CinryzeZ (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities.
Specifically, the FDA has three comments related to a portion of the cleaning validation for industrial scale manufacturing, of which only one requires additional unplanned activity. The company expects that the additional activity required to address this comment can be completed in a short time frame.
The FDA also noted that it has not yet completed the review of ViroPharma’s January 2012 updated responses to observations specific to the September 2011 inspection of the Amsterdam facility.
There are no remaining technical comments posed by FDA in the complete response letter. The company intends to provide an update to shareholders on specific timing of resubmission and expected action dates during the 2011 Financial Results conference call to be held later this month.
“We and our partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible.” – Robert Pietrusko ViroPharma’ Vice President Global Regulatory Affairs and Quality.
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the U.S., Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.
In the E.U., the product is approved by the EMA for the 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.
Cinryze is for intravenous use only.
Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze, and in patients receiving off-label high dose C1 inhibitor therapy. With any blood or plasma derived product, there may be a risk of transmission of infectious agents.
The risk has been reduced by screening donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.
The most common adverse reactions in clinical trials associated with Cinryze were rash, headache, nausea, erythema, phlebitis and local reactions at the injection site. Adverse events of sinusitis and upper respiratory infection also were observed in clinical trials. No drug-related serious adverse events (SAEs) were reported in clinical trials.
Please visit http://www.viropharma.com/products/cinryze.aspx for the full U.S. Prescribing Information; the prescribing information for other countries can be found at www.viropharma.com.
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