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Food and Drug Administration


87th Meeting – July 13, 2006

Committee Updates

The Committee listened to the following briefings and updates: Dr. Jerry Holmberg presented an overview of the May 2006 DHHS Advisory Committee on Blood Safety and Availability. Dr. Sanjai Kumar summarized the July 12, 2006 FDA Workshop on Testing for Malarial Infections in Blood Donors. Dr. James Allen, Chairman, BPAC, presented an overview of the findings of the Subcommittee Report of the Office of Blood Research and Review Site Visit, Review of Intramural Research. Dr. Jesse Goodman, Director, CBER, then commented on the report and emphasized the importance of research at CBER, a science-led organization. The updates were concluded by Dr. Maria Rios’ presentation on West Nile Virus.

Topic I

FDA Review of Nabi Biopharmaceutical’s Hepatitis B IGIV for Prevention of Recurrent HBV Disease after Orthotopic Liver Transplantation

Dr. Charles Maplethorpe introduced the topic with questions for the Committee. He was followed by Nabi’s presentation by Dr. Henrik Rasmussen. Following Dr. Rasmussen’s presentation, Dr. Maplethorpe presented the FDA clinical review of Nabi’s submission. This was followed by FDA’s statistical review by Dr. Jessica Kim. During the Open Public Hearing, Dr. Imagawa presented findings from the University of California, Irvine and summarized written statements provided by the Hepatitis B Foundation, Dr. Fung of Cleveland Clinic and Dr. Sher of USC School of Medicine, and Dr. Pruett of University of Virginia. Additionally, Lisa Tobin of the American Liver Foundation and Jan Gyn, a liver transplant recipient, addressed the Committee.

The Committee then discussed and voted on the following questions:

1. Please comment on Nabi’s post hoc inclusion and exclusion criteria for the classification of subjects as successes or failures following HBIG administration in the setting of orthotopic liver transplantation (OLT).

The Committee noted that there is a wide difference of opinion between FDA and Nabi regarding which patients should be considered successes, failures or excluded from the study criteria. Several Committee members considered FDA’s inclusion and exclusion criteria too stringent.

2. Given the observational nature of the information provided, the data limitations (including a priori definitions), and the lack of analysis plan, is inference about the outcomes of Nabi’s HBIG administration in this setting appropriate?

The Committee stated it was not possible to comment on this question since FDA and Nabi failed to reach agreement on which patient treatments could be considered as successes, failures or should be excluded.

3. Do the submitted data from retrospective chart reviews, an uncontrolled PK assessment and an open label access program demonstrate efficacy of Hepatitis B Immune Globulin (H) (HBIG) (Nabi-HBTM) for the OLT HBV immunoprophylaxis indication?

The Committee voted on question 3, as follows: 9 yes votes, 2 no votes and 3 abstained. Several committee members noted their difficulty in voting on this question in the absence of resolution of the uncertainty concerning the outcomes of treatment in the study patients.

Topic II

Review of the Research Programs in the Laboratory of Bacterial, Parasitic and Unconventional Agents, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER (May 25, 2006)

An overview of CBER research in the context of FDA’s critical path was provided by Dr. Carbone. Dr. Atreya then presented an overview of OBRR’s regulatory responsibilities and research programs. Subsequently, Dr. Nakhasi provided an overview of the Division of Emerging and Transfusion Transmitted Diseases research program and Dr. Asher reviewed the Laboratory of Bacterial, Parasitic and Unconventional Agents research, as well as his own research program. Dr. Piccardo, Dr. Nakhasi, Dr. Duncan, Dr. Selvapandiyan, Dr. Debrabant and Dr. Kumar then provided overviews of their respective research programs.

The Committee then met in closed session to discuss the site visit report of the investigators included in the May 25, 2006 review.

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