Major Amendment Memo -Eloctate

     Memorandum

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service
 Food and Drug Administration
Center for Biologics Evaluation and Research

 

From: Nancy Kirschbaum, PhD, Committee Chair and Product Discipline Reviewer

To: Basil Golding, MD, Director, Division of Hematology, OBRR

Subject: Designation of BL STN 125487/0.27 as a Major Amendment

 

Designation of Amendment 125487/0.27 as Major
BL STN 125487/0 for Antihemophilic Factor (Recombinant), Fc Fusion Protein was submitted by Biogen Idec, Inc. (Biogen) on 08 March 2013 under the PDUFA V program. The action due date for the BLA is 07 March 2014. On 15 November 2013, Biogen submitted amendment 125487/0.27, which contained the process validation protocols that will be used to execute the manufacture and control of drug product intermediate strength conformance lots. On behalf of the review committee for BL STN 125487/0, I recommend designation of 125487/0.27 as a major amendment.

Justification for Major Amendment Designation
SOPP 8402 1 defines a major amendment as a submission of information to a pending application that extends the review clock. According to section V.D., a major amendment may contain a substantial amount of new manufacturing information and data not previously submitted to or reviewed by the Agency. Amendment 125487/0.27 contains four process validation study protocols. The four protocols will be used to conduct additional conformance lot manufacture in order to complete process validation activities. Submission of process validation data generated from conformance lot manufacture according the protocols provided in amendment 125487/0.27 is projected for the end of February 2014. As such, the companion amendment will be received so near the action due date as to preclude adequate time for complete review (see section V.H., SOPP 8402). Since amendment 125487/0.27 provides substantial new information and is linked to a future amendment projected for submission near the action due date, amendment 125487/0.27 may be classified as a major amendment.

New Action Due Date
According to section V.E.1.b. of SOPP 8402, a major amendment extends the action due date of an original application by three (3) months. If the major amendment designation receives concurrence by the Director, Division of Hematology, OBRR, the new action due date for BL STN 125487/0 will be 07 June 2014.

SOPP 8402: Designation of Amendments as Major, Version #4, October 1, 2012