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Vaccines, Blood & Biologics

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Email, January 11, 2011 - Corifact

From:   Cagungun, Nannette
Sent:     Tuesday, January 11, 2011 11:16 AM
To:       'David.Desris@cslbehring.com'
Subject:            STN 125385/0

Importance:      High
Dear David,

CSLB stated in their BLA that they commit to --------------------------------(b)(4)-----------------------------.  Please check the language of the commitment below    and let me know if it is acceptable.  If it is, CSLB will need to send a letter to the file that states the commitment.

CMC

CSL Behring commits to introduce ----------------------------------------------(b)(4)-------------------------------------------- according to the plan summarized in Module 3.2.R.4 of the BLA, which includes a ---------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------.

Clinical

In addition, we would like CSLB to provide more information on the following post-marketing data:

1.         Case -------(b)(6)------ concerns a 51-year-old female patient who was treated with Factor XIII concentrate -----------------------------(b)(4)---------------------------------------------- from 01 January 1999 to 03 January 1999.  In the context of postoperative fulminant hepatitis with suspected marked postoperative liver damage, the patient developed DIC. The causality to Factor XIII concentrate administration was assessed as unlikely.

            Did the subject above have a FXIII deficiency? Was the FXIII concentrate treatment done with FibrogaminP?  What was the dose? What was  the post-operative thrombo-embolic event prior to development of DIC? Can you provide details?

2.         Case ----(b)(6)--- concerns a 7-day-old male with asplenia syndrome, univentricular heart and single atrium, total anomalous pulmonary venous connection, and pulmonary congestion with postoperative chylothorax who was treated with Factor XIII concentrate and fresh frozen plasma. The patient developed embolism, suspicion of cerebral embolism, suspicion of shunt occlusion, and sudden cardiac arrest after removal of a CV catheter after cardiac surgery under extracorporeal circulation. The case outcome was fatal. The causality to Factor XIII concentrate administration for this case was assessed as possible. However, cardiac surgery and CV lines are additional causative agents for thrombus formation

Did the subject above have FXIII deficiency? When did it happen (what year)? Was the FXIII product FibrogaminP? What was the dose?

Please provide us with the requested information as soon as possible.

Best regards,
Nannette

Nannette Cagungun, MS, PD, RAC Regulatory Project Manager OBRR/CBER/FDA, HFM-380 1401 Rockville Pike Rockville, MD 20852-1448 Tel: (301) 827 6174 Fax: (301) 827 2857 Email: nannette.cagungun@fda.hhs.gov