Information Request Email, July 24, 2013 - ALPROLIX

From: Thompson, Edward
Sent: Wednesday, July 24, 2013 7:27 AM
To: 'Nadine D. Cohen PhD (nadine.cohen@biogenidec.com)'
Cc: Staschen, Carl-Michael; Kirschbaum, Nancy (Nancy.Kirschbaum@fda.hhs.gov); Debra Segal
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 “Summary of Clinical Pharmacology Studies: Addendum June 2013”
The applicant states on page 7: 
 2.3. Conclusions:
 In analyzing the pediatric FIX PK data obtained to date, together with PK data obtained in adult and adolescent subjects, the following conclusions can be drawn:
 Consistent with the known impact of age on PK of coagulation factors [BeneFIX® Prescribing Information 2011], there appears to be a decrease in IR and an increase in CL in pediatric patients <12 years of age. These differences should be taken into account when dosing children <12 years of age.
1.Please explain how the observed differences in pharmacokinetics can be translated into a more specific and practical dosing recommendation for pediatrics 2 to < 6 years of age. We realize that there appear to be only minor differences in relevant pk parameters between adults and children 6 to 12 years of age.

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 August 6, 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 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

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