MID-CYCLE COMMUNICATION
Application type and number: Original BLA STN 125512/0
Product name: Antihemophilic Factor (Recombinant), Porcine Sequence [OBIZUR]
Applicant: Baxter Healthcare Corporation 
Action Due Date: July 26, 2014
Meeting date & time: Tuesday, March 25, 2014, 1:00 – 2:00 PM
Telecon Numbers Toll-free: 1-8554229837; Conference Code: ----(b)(4)-------
Committee Chair: Natalya Ananyeva, PhD
RPM: Iliana Valencia
Purpose: To provide an update on the review status of the BLA
FDA Attendees:
Natalya Ananyeva, PhD, OBRR/DH/LH
Qiao Bobo, PhD, OCBQ/DMPQ/BII
Iliana Valencia, OBRR/DBA/RPMB
Baxter Attendees 
Susan Schober-Bendixen, Vice President, Quality Compliance and Safety
Iraj Daizadeh, Senior Manager, Regulatory Affairs
Kien Du, Manager, Regulatory Affairs
Heinrich Farin, Associate Director, Clinical Research
Mathias Ferencic, Senior Project Manager
Peter Leidenmuehler, Senior Research Scientist
Linda Lemieux, Associate Director, Regulatory Affairs
Christoph Leonhart, Vice President, Quality
Christina Piskernik, Manager Research and Development
Donna Welch, Director, Quality
Other Attendees
So Hyun Kim, Independent Assessor, Eastern Research Group 
Discussion Summary:
1. To date, no significant issues have been identified by the review committee with the product-related, pharmacological and clinical data submitted in the BLA. However, the DMPQ reviewer identified deficiencies in the equipment qualification and validation of the commercial lyophilization process for the final product. These deficiencies were discussed at the teleconference on March 25, 2014.

2. Information Requests (IR)

a. IR from the DMPQ reviewer related to the lyophilization process was sent to Baxter on March 19, 2014. During this communication, Baxter confirmed that they will submit responses to the IR by April 7, 2014.

b. FDA informed Baxter that an IR with product-related CMC items, and possibly clinical questions, is in preparation and will be sent to Baxter before April 7, 2014.

3. Regarding inspection of the Baxter (b)(4) facility during ----(b)(4)------, Baxter should submit a resolution plan for all items in Form FDA 483, with tentative completion dates for each item, within 15 business days from the inspection completion date. The resolution plan and final responses to the 483 items should be submitted in electronic format as amendments to the BLA. During this communication, Baxter confirmed that they will submit the resolution plan by March 28, 2014.

4. Inspection of (b)(4) facility in ----(b)(4)------, is planned for --------(b)(4)-------------. Baxter asked FDA to not schedule inspection activities on ---(b)(4)----- as it is a (b)(4) (b)(4), which FDA will take into consideration. 

5. The review of the clinical data to date did not raise major safety concerns. The current thinking of the review committee is that a Risk Evaluation and Mitigation Strategy (REMS) is not required.

6. The current thinking of the review committee is that this BLA will not be presented at Blood Products Advisory Committee meeting.

7. As agreed upon by both parties, Baxter and FDA will meet face-to-face for the Late-Cycle Meeting on Thursday, May 22, 2014, 1:00 – 2:30 PM. 
END

