Information Request Email, March 19, 2013 - ALPROLIX

From: Thompson, Edward
Sent: Tuesday, March 19, 2013 4:44 PM
To: 'Nadine D. Cohen PhD (nadine.cohen@biogenidec.com)'
Cc: Debra Segal; Kirschbaum, Nancy (Nancy.Kirschbaum@fda.hhs.gov); Staschen, Carl-Michael
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:

Clinical Pharmacology
 Regarding Phase 3 clinical study No. 998HB102:
•Please provide a pooled summary table of all six, 50 IU/kg dose PK studies in the four arms. Please use the same table format as submitted in Table 2 from Module 2.5 Clinical Overview, Section 3.1.1, Conventional PK Analysis (page 15). The table should not include data from competitor BeneFIX®.
•Please include in the PK parameter summary table, the arithmetic mean, averaged over all six trials, followed by the coefficient of variation in percent (%CV) and the 95% confidence interval in parenthesis for: Cmax, AUCinf, CL, V1, Vss, half-life (alpha), half-life (beta), MRT, IR, time to 1% FIX activity, and time to 3% FIX activity.

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 April 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.

Please send an acknowledgement message to me 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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