Date: July 30, 2007
To: To File (BLA STN 125251/0)
From: Hon-Sum Ko, Medical Officer, HFM-392
Through: Toby Silverman, Branch Chief, HFM-392
CC: Franklin Stephenson, RPM, HFM-370
Applicant: Octapharma Pharmazeutika Produktionsges.m.b.H.
Product: Wilate (von Willebrand Factor/Factor VIII Concentrate (Human)
Subject: Submission dated 7/23/07
Octapharma has submitted an amendment on July 23, 2007 (received by CBER on July 25, 2007).
This is a clinical amendment for the final reports of von Willebrand disease clinical studies TMAE-104 and TMAE-106. These studies were ongoing at the time of BLA submission in December 2006, and their available data were included to support the original application.
The submission consists of 15 volumes. Together with the submission of the two final clinical study reports, Octapharma has also provided the following:
- Updated Clinical Overview and Clinical Summary in Module 2
- Revised Electronic datasets for Studies TMAE-104 and TMAE-106
- Revised draft labeling (paper and electronic)
- Periodic Safety Update Reports (product approved in Germany).
This submission qualifies as a major amendment to the original BLA and may be designated as such.