Mid Cycle Meeting Summary - Wilate, August 31, 2009

DATE: 31-Aug-2009

FROM: Pauline Cottrell, DBA, HFM380    

RE:  Mid Cycle Meeting Summary for STN: 125251/0

Attendees: Pauline Cottrell, Timothy Lee, Nisha Jain, Hon Sum Ko, Jonathan   Rose, Loan Nguyen, Shiowjen Lee

SPONSOR: Octapharma Pharmazeutika Produktionsges.m.b.H.(Octapharma)

PRODUCT: Coagulation Factor VIII/von Willebrand Factor Complex (Human)

Due date: 4-Dec-09

To:     File

 

Background:

Dr. Lee reviewed briefly the history of this application.  He also reviewed the Telecon held on Aug. 11, 2009, with Octapharma to discuss the Potency Assay.  FDA asked Octapharma to clarify their SOP for the VWF:RCo assay.  FDA also asked Octapharma to propose how they will correlate their modified assay to the standard assay so that other clinical laboratories’ assay values will correlate to Octapharma’s modified assay and therefore determine treatment for patients.

 

Meeting:

Dr.Jain suggested that Octapharma provide their proposal soon and request that at least one lot of samples be sent to additional testing facilities and that at least one of those be U.S. testing lab.

The clinical and statistical review (Dr. Ko and Dr. S. Lee) indicated that -(b)(4)-         ----------------------------------------------------------------------------- but will support the indication for treatment of bleeding episodes if the quality of data is not to be considered.

Dr. Ko said that a meeting with upper management is scheduled to discuss this application with regard to the quality of data.

Jonathan Rose (OBE) indicated that the PVP plan needs some revisions but no show stoppers were revealed.  He indicated that additional information may be required at a later time during the review after the problems with the modified assay is resolved.  Requesting information at this time would be premature.

Action Items:
•Meeting with upper management on Sept. 8, 2009, to determine quality of data and how to proceed.
•Contact Octapharma requesting proposal for correlating the difference in assay methods between, manual, standard and modified VWF:RCo assays after the Sept. 8th meeting.
