
Information Request, July 22, 2013- Eloctate

 

 
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

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


 

 Our Reference:  BL 125487/0

Biogen Idec Inc.
 Attention:  Ms. Debra Segal
July 22, 2013
 Sent by email

Dear Ms. Segal:

We are reviewing your March 7, 2013 biologics license application (BLA) for Antihemophilic Factor (Recombinant), Fc Fusion protein.  We are providing the following comments and request for additional information to continue our review:

Regarding “Summary of Clinical Pharmacology Studies: Addendum June 2013”

The applicant states on page 7:

2.3. Conclusions:
 In analyzing the pediatric FVIII 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 [ADVATE USPI 2012; Kogenate FS USPI 2013], there appears to be a decrease in t˝ 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.2.

The review of this submission is on-going 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 5, 2013 referencing the date of this request.

The action due date for this file is March 8, 2014.

If you have any questions, please contact me at (301) 827-6116.

Sincerely,

 

Leigh Pracht
 Regulatory Project Manager
 FDA/CBER/OBRR/DBA/RPMB
