Addendum to pharmacovigilance plan review, January 30, 2014 - ALPROLIX

Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Biostatistics and Epidemiology

 

MEMORANDUM ADDENDUM

 

Date: Jan 30, 2014

From:  Bethany Baer, MD, Medical Officer, Division of Epidemiology

To: Edward Thompson, Regulatory Project Manager, Division of Blood Applications, Office of Blood Research and Review       

Through:Christopher Jankosky, MD, MPH, Chief, Pharmacovigilance Branch
  David Martin, MD, MPH, Acting Deputy Director, Office of Biostatistics and Epidemiology

Subject: Addendum to pharmacovigilance plan review for initial licensure

Applicant: Biogen Idec    

Product: Coagulation factor IX (Recombinant), Fc Fusion protein, also known as rFIXFc or Alprolix

Proposed Indication: Control and prevention of bleeding episodes in hemophilia B including  perioperative management and routine prophylaxis.             

Submission Type:BLA 125444

PVP Submission Date: January 29, 2013

Action Due Date: March 29, 2014

MEMORANDUM ADDENDUM
 This memorandum is an addendum to the August 21, 2013 memorandum reviewing the pharmacovigilance plan for initial licensure for Coagulation Factor IX (Recombinant), also known as Alprolix. 

On Jan 6, 2014, the sponsor submitted Risk Management Plan Version 2.0 as amendment 49 for the BLA 125444.  This new version of the Alprolix pharmacovigilance plan incorporated the agreed upon changes included in the sponsor’s Aug 9, 2013 amendment 22.  As these alterations were reviewed in the Aug 21, 2013 Division of Epidemiology memorandum, the original memorandum is attached to this addendum. 

There was no new material (not previously reviewed) provided in the Jan 6, 2014 Risk Management Plan Version 2.0.

OBE agrees with the sponsor’s submitted Risk Management Plan Version 2.0.
 

  


Related Memo

•Pharmacovigilance Plan Review -PVP, August 21, 2013 - ALPROLIX	[ARCHIVED] 
	