Information Request, May 16, 2013 - ALPROLIX

From:                              Thompson, Edward
Sent:                               Thursday, May 16, 2013 10:15 AM
To:                                  'Nadine D. Cohen PhD (nadine.cohen@biogenidec.com)'
Cc:                                  Staschen, Carl-Michael; 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:

Clinical Pharmacology
Please note that Tables provided in the Clinical Pharmacology section of your application must be based on arithmetic means as specified below:
1.Regarding 2.7.2 Summary of Clinical Pharmacology Studies: a.Please indicate the type of mean that has been used in Tables 1, 2, and 12. If means other than arithmetic were used please recalculate and resubmit the tables using arithmetic means. Also recalculate and resubmit Table 4 and Table 6 using arithmetic means.

2.Regarding 2.5 Clinical Overview: a.Please recalculate and resubmit Table 2 using arithmetic means.

3.Regarding Population Pharmacokinetics Report: a.Please indicate the type of mean that has been used in Table 21. If means other than arithmetic were used please recalculate and resubmit the table using arithmetic means.

4.Regarding 1.11.3 Efficacy Information Amendment – Response to FDA Request for Information a.Please confirm that arithmetic means (as requested, 03/01/2013) have been used in Table 1.
b.Please confirm that arithmetic means (as requested, 03/20/2013) have been used in Tables 1, 2, and 3.


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 May 30, 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 email message acknowledging 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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