Late Cycle Meeting Summary CoverSheet - ALPROLIX

DEPARTMENT OF HEALTH & HUMAN SERVICES
 Public Health Service



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

Our Reference: BL 125444/0

Biogen Idec, Inc.
 Attention: Nadine D. Cohen, PhD
 14 Cambridge Center
 Cambridge, MA 02142

Dear Dr. Cohen:

Attached is a copy of the memorandum summarizing your September 12, 2013 late-cycle meeting with CBER. This memorandum constitutes the official record of the meeting. If your understanding of the meeting outcomes differs from those expressed in this summary, it is your responsibility to communicate with CBER as soon as possible.

If you have any questions, please contact Edward Thompson at (301) 827-9167.

Sincerely yours,

Basil Golding, MD
 Director
 Division of Hematology
 Office of Blood Research and Review
 Center for Biologics
 Evaluation and Research
