System Info - 104087 SHONE, DEANNA 02-Sep-2009 14:56:57 SHONEDE
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125259/0 Office: OVRR
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 02-SEP-2009 10:40 AM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
PERC Concurrence Memo
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Greeley, George
Sent: Wednesday, September 02, 2009 10:40 AM
Subject: BLA 125259 Cervarix
The Ceverix (Human Papillomavirus Bivalent [Types 16 and 18] recombinant vaccine) partial waiver/deferral/plan/assessment was reviewed by the PeRC PREA Subcommittee on July 08, 2009. The Division recommended a partial waiver from 0-8 years because product does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in this/these subpopulation(s) AND is not likely to be used in a substantial number of pediatric patients in this/these pediatric subpopulations. The deferral of studies for 9 year olds because the product is ready for approval in adults and completed studies from 10-17 years. The PeRC agreed with the Division to grant a partial waiver and deferral along with the assessment for this product.
The PeRC recommended modifying the pediatric page to reflect the only reason for waiver as being too few children with disease/condition to study. The page should also be updated to reflect that pediatric studies were completed for patients 10-17 years of age.
Regulatory Health Project Manager
Pediatric and Maternal Health Staff
Office of New Drugs
10903 New Hampshire Ave.
Bldg #22, Room 6467
Silver Spring, MD 20993-0002
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