Information Request Email, March 14, 2014 - ALPROLIX

From: Thompson, Edward
Sent: Friday, March 14, 2014 3:26 PM
To: 'Nadine D. Cohen PhD (nadine.cohen@biogenidec.com)'
Cc: Debra Segal; Kirschbaum, Nancy (Nancy.Kirschbaum@fda.hhs.gov); Jain, Nisha; Omokaro, Stephanie
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 request that you make the following postmarketing commitment:
1.To continue study 9HB02PED, an ongoing, open-label, multi-center study for evaluating the safety, pharmacokinetics and efficacy of Coagulation Factor IX (Recombinant), Fc Fusion Protein for routine prophylaxis and control of bleeding in previously treated patients <12 years old, with updates in annual reports and submission of a final study report to FDA.
2.Please provide a projected time line for completion of the study and the submission of the final study report.

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 17, 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

THIS DOCUMENT IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL AND PROTECTED FROM DISCLOSURE UNDER APPLICABLE LAW. 
 If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying or other action based on the content of this communication is not authorized. If you have received this document in error, please notify us immediately by telephone and return it to us at the above address by mail. Thank you.
