Record of Telephone Conversation - Cervarix, Sept. 2, 2009, AM

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  

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  02-SEP-2009 10:40 AM                Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Other

Author:  HELEN GEMIGNANI

Telecon Summary:

PERC Concurrence Memo

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

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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.

Thank you.

George Greeley

Regulatory Health Project Manager

Pediatric and Maternal Health Staff

Office of New Drugs

FDA/CDER

10903 New Hampshire Ave.

Bldg #22, Room 6467

Silver Spring, MD 20993-0002

301.796.4025

 

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