Filing Memo - Cervarix, May 18, 2007

 

 

MEMORANDUM
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Review
Office of Vaccines Research and Review

FILING MEMO

Re: STN #125259/0
Title: “Cervarix® (Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed)
Intramuscular Injection”
Sponsor: GlaxoSmithKline Biologicals
Date: May 18, 2007
To: File
From: Gopa Raychaudhuri, Ph.D.
Chairperson, BLA Review Committee
Signature:
 

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The filing meeting was conducted via e-mail on May 3, 2007 (see attachment). Each member of the review team was asked to evaluate whether the information included in the BLA in his/her area of expertise was adequate to allow the reviewer to conduct a meaningful review. Each member of the review team responded that the sections in the BLA relevant to his/her area of review were acceptable for filing (see list below). Based on input from reviewers, as well as the assessment of the chairperson (Dr. Gopa Raychaudhuri) and the regulatory co-ordinator (Ms. Helen Gemignani), the review team agreed that the Cervarix BLA can be filed. CBER will issue a Filing letter by May 28, 2007 (Filing Action milestone).

The following reviewers indicated his/her concurrence with the decision to file the BLA:

Nancy Miller, MD	Clinical
Robin Levis, Ph.D.	Product, Facility, Pre-clinical immunogenicity
Martha Lee, Ph.D.	Statistics (clinical)
Lev Sirota, Ph.D.	Statistics (assay validation)
Steve Kunder, Ph.D.	Pre-clinical toxicology (standard toxicology studies)
Liz Sutkkowski, Ph.D.	Pre-clinical toxicology, Product (adjuvant)
Marion Gruber, Ph.D.	Pre-clinical toxicology (reprotoxicology studies)
Rebecca Olin	Facility inspection
Manette Niu, MD	Epidemiology (post-marketing commitments)
Solomon Yimam	Bioresearch monitoring
Vada Perkins, RN	Electronic format of BLA document
Helen Sullivan	Labeling