Information Request Email, February 27, 2014 - ALPROLIX

From: Thompson, Edward
Sent: Thursday, February 27, 2014 4:09 PM
To: Nadine D. Cohen PhD (nadine.cohen@biogenidec.com)
Cc: Debra Segal; Peng, Ze (Ze.Peng@fda.hhs.gov); Kirschbaum, Nancy (Nancy.Kirschbaum@fda.hhs.gov)
Subject: Information Request for BL 125444/0

Contacts: Nadine D. Cohen PhD

Dear Dr. Cohen:

We are reviewing your December 28, 2012 biologics license application (BLA) for Coagulation Factor IX (Recombinant), Fc Fusion Protein. We are providing the following comments and request for additional information to continue our review:

You provided the updated stability data on both rFIXFc drug substance and drug product on 27 September 2013. However, some of the acceptance criteria used in these ongoing stability studies are inconsistent with those listed in the post-approval stability protocols, e.g., the limit for residual moisture in the ongoing stability studies for drug product (2-8°C storage condition) is -(b)(4)-, whereas it is -(b)(4)- in the respective post-approval stability protocol. Please update the acceptance criteria in all ongoing stability studies for both rFIXFc drug substance and drug product, and keep them consistent with the ones in the post-approval stability protocols, which were provided in the amendment dated 27 September 2013.

The review of this submission is ongoing and issues may be added, expanded upon, or modified as we continue to review this submission.

Please submit your response to this information request as an amendment to this file by March 6, 2014 referencing the date of this request. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.

The action due date for this file is March 29, 2014.

Please send an acknowledge message for receipt of this request.

If you have any questions, please contact me at (301) 827-9167.

Sincerely,

Edward Thompson
 Regulatory Project Manager
 FDA/CBER/OBRR/DBA/RPMB

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