From: Maruna, Thomas
Sent: Wednesday, October 08, 2014 11:24 AM
To: Daizadeh, Iraj (iraj_daizadeh@baxter.com)
Cc: Ananyeva, Natalya; Jain, Nisha
Subject: Information Requested - PMC Committment: BLA 125512 - Please Respond by October 10, 2014
Importance: High
Baxter Healthcare Corporation
Attention: Iraj Daizadeh, PhD
October 8, 2014
Sent by email
Dear Dr. Daizadeh:
We are reviewing your November 25, 2013 biologics license application (BLA) indicated for the treatment and prevention of bleeding episodes in patients with acquired inhibitory antibodies to human factor VIII (i.e., acquired hemophilia patients) for the following:
STN                       Name of Biological Products
BL 125512/0         Antihemophilic Factor (Recombinant), Porcine Sequence
The Agency has classified your planned Treatment Registry study under Protocol 241302 listed in the Pharmacovigilance Plan as a post-marketing commitment. Please commit to the following:
Baxter Healthcare Corporation commits to evaluate efficacy and safety of OBIZUR in adults with acquired hemophilia A in the Treatment Registry study under Protocol 241302, add title
* Study/trial completion date: state the projected date for completing the study
* Final Study Report submission date: state the projected date for submitting the final report for FDA review
Please submit your response with a milestone schedule for the Treatment Registry by October 10, 2014, referencing the date of this request.
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.
The action due date for these files is October 25, 2014.
If you have any questions, please contact me at (240) 402-8454 or thomas.maruna@fda.hhs.gov.
Very Respectfully,
Thomas J. Maruna, MSc, MLS(ASCP)CM
Lieutenant, U.S. Public Health Service
Senior Regulatory Management Officer
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Blood Research and Review
10903 New Hampshire Ave.
Silver Spring, MD 20993
thomas.maruna@fda.hhs.gov
O: (240) 402-8454
www.usphs.gov
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