Information Request Email, January 9, 2013 - ALPROLIX

From: Thompson, Edward
Sent: Wednesday, January 09, 2013 1:05 PM
To: 'Nadine D. Cohen PhD (nadine.cohen@biogenidec.com)'
Cc: Debra Segal; Baer, Bethany; Kirschbaum, Nancy
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 determined that the following information is necessary to continue our review:
1.Please provide a Pharmacovigilance Plan completed in ICH format with Safety Specifications and a Risk Management Plan for factor IX fusion protein (BLA 125444). The FDA’s guidance document on pharmacovigilance planning is available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm129411.htm

The review of this submission is on-going 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 February 1, 2013 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 December 28, 2013.

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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