Filing Letter - ALPROLIX

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
 1401 Rockville Pike
 Rockville, MD 20852-1448


Our STN:  BL 125444/0 

Biogen Idec Inc.
 Attention: Nadine D Cohen, PhD
 14 Cambridge Center
 Cambridge, MA 02142

Dear Dr. Cohen:

This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated December 28, 2012 for Coagulation Factor IX (Recombinant), Fc Fusion Protein to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today.  The review classification for this application is Standard.  Therefore, the review goal date is December 28, 2013.  This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted. 

We are reviewing your application according to the processes described in the Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products.  Therefore, we have established internal review timelines as described in the guidance, which include the timeframes for FDA internal milestone meetings.  We plan to hold our internal mid-cycle review meeting on June 11, 2013.  Please be aware that the timelines described in the guidance are flexible and subject to change based on workload and other potential review issues (e.g., submission of amendments).  We will inform you of any necessary information requests or status updates following the milestone meetings or at other times, as needed, during the process. 

We will contact you regarding your proposed labeling no later than November 28, 2013.  If post-marketing study commitments (506B) are required, we will contact you no later than November 28, 2013.

At this time, we have no plans to present this application to an Advisory Committee.

Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application.  Following review of the application, we shall advise you in writing of any action we have taken and request additional information, if needed.

If you have any questions, please contact the Regulatory Project Manager, Edward M. Thompson, at (301) 827-9167.

Sincerely yours,

 

Iliana Valencia
 Chief
 Regulatory Project Management Branch
 Office of Blood Research and Review
 Center for Biologics
 Evaluation and Research
