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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Final Response Memo, April 16, 2013 - SOLX® System

DEPARTMENT OF HEALTH AND HUMAN SERVICES                                                                        

PUBLIC HEALTH SERVICE                                                                                                                                                                                                                                                       

FOOD AND DRUG ADMINISTRATION                                                                                                        

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH                                         
Division of Biostatistics (HFM-215)

Statistical Review and Evaluation

                                                                                                        

Type/Application ID/Amendment #: NDA/BN 110059

Subject: HEMERUS LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX® Additive

Applicant: Hemerus Medical, LLC

Indications for Use (Revised):       
The LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX® Additive also called “SOLX® System” is intended for the manufacture of:
• CPD/AS-7 Red Blood Cells (RBC), Leukocytes Reduced prepared at ambient temperature and, placed at 1 to 6° C within 8 hours of collection. CPD/AS-7 Red Blood Cells, Leukocytes Reduced may be stored at 1 to 6° C for up to 42 days after collection.
• Fresh Frozen Plasma (FFP), Leukocytes Reduced prepared and placed in a freezer at -18° C or colder within 8 hours of collection. Fresh Frozen Plasma (FFP), Leukocytes Reduced may be stored at -18° C or colder for up to one year after collection.

Primary Statistical Reviewer:  Chinying Wang, Ph. D. (HFM-219)
Supervisory Concurrence:
1st Level Review
Supervisor Name: Tie-Hua Ng, Ph. D.
Supervisor Title: Team Leader, OBE/DB/TEB
Concur ______________ Not Concur ______________  
Supervisory Signature

2nd Level Review
Supervisor Name: Boguang Zhen, Ph.D.
Supervisor Title: Branch Chief, OBE/DB/TEB
Concur ______________ Not Concur ______________  
Supervisory Signature

Review Project Manager: Iliana Valencia (OBRR/DBA/RPMB)

Cc: HFM-380/Xuan Chi, M. D., Ph. D. (OBRR/DH/LCH)
HFM- 215 /Chronological File (OBE/DB)
HFM-215/Estelle Russek-Cohen, Ph. D. (OBE/DB)
HFM-215/Boguang Zhen, Ph. D. (OBE/DB/TEB)
HFM-215/John Scott, Ph. D. (OBE/DB)

Review SUMMARY
The study was conducted according to protocol PC387580, “In Vitro and In Vivo Evaluation of Hemerus LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX® Additive”. Based on the reported results, the clinical study showed that the primary endpoints of RBC mass recovery, leukorecution efficiency, hemolysis at end of storage, and 24-hour radiolabeled recovery were met for all SOLX® RBC processing groups.

The updated statistical review memo was completed and concurred on August 28, 2012. A Complete Response (CR) letter was issued on August 31, 2012. Hemerus submitted the responses to CR letter in the Amendment 15 dated February 26, 2013. No statistical item was included in the CR letter.

Statistical Comment
There are no additional statistical comments for this supplement.