Response to CR letter - Wilate, August 6, 2009

DATE: 6-Aug-2009

FROM: Pauline Cottrell, DBA, HFM380    

RE:  Response to CR letter, Status: STN 125251/0 Meeting Summary

Attendees: Pauline Cottrell, Timothy Lee (SL), Jonathan Rose, Donald Lebel, Hon Sum Ko, Shiowjen Lee, Iftekhar Mahmood, Marion Michaelis, Loan Nguyen, Solomon Yimam, ,Craig E Zinderman, Nisha Jain

SPONSOR: Octapharma

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

Due date: 4-Dec-09

To:     File

 

Background:

Application submitteed 12-Dec-2006

Deficiencies identified 7-Feb-2007

Major Amendment recieved: 25-Jul-2007

CR letter sent 8-Jan-2008

Response to CR letter received 4-Jun-09

Meeting scheduled to determine status of this application.

 

Meeting Minutes:

Dr. Lee reviewed the history of the application.  He also noted that this product is licensed in Europe.

Dr. Lee explained that the main deficiencies were with regard to the Potency assay and the PK data.

Dr. Lee said on preliminary review that the responses to the CMC portion of the CR letter, questions 28-35, appear acceptable but further review will be performed.  He explained that the problems with the previous assays seem to have been resolved due to major changes in Octapharma’s method for testing the product.  A request for conformance lots are still required and Dr. Lee asked that they be requested as soon as possible.

Mr. Lebel stated that the problems with the difference in assay values noted previously seem to be resolved but further testing is required.

Dr. Lee told Dr. Mahmood that the PK data submitted should be reviewed at this time and to assume the validation of the assays are acceptable.

Dr. Kosaid that upon initial review of the clinical and statistical responses Octapharma submitted, they used the criteria that FDA requested and for the “Treatment of bleeds” indication, has met the criteria.

 

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Dr. Jain asked if the new studies FDA had previously request in the CR letter would still need to be performed.

Dr. Kosaid that upon initial review of the responses, for the indication of bleeding episodes, new studies would not be necessary based on the re-analysis of the previous samples.

Dr. Ko also said that the pediatric studies are still ongoing.

Pauline Cottrell stated that since the submission of this application in 2006, changes in the regulation, FDAAA, now affect this application and there are new requirements to be addressed.    

BiMo: Solomon Yimam said that the BIMO inspection was completed and did not reveal any problems that impact the data submitted, therefore no additional action is required.

DMPQ: Marion Michaelis said that DMPQ will be issuing a waiver of inspection of facilities for this application.

APLB said that the PNR review will be conducted within 90 days of approval per SOPP.

This product is Orphan designated and therefore PeRC is not applicable.

The review committed determined that this application will not need to go before BPAC since it is not a new entity.

Craig Zinderman (OBE) requested that Octapharma submit their Pharmacovigilance Plan (PVP) plan as soon as possible and will send letter ready language to Ms. Cottrell in order to request the required plan.

End.

Action Items:
•Schedule telecon with Octapharma to request conformance lots and discuss Potency assay.
•Send IR to request PVP to respond in 3 weeks.
•Schedule next meeting
