Record of Telephone Conversation - December 2, 2009 - Prevnar 13

System Info - 120216  SMITH, MICHAEL J  17-Feb-2010 11:48:20  SMITHM

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125324/0    Office: OVRR  

Product:
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Applicant:
Wyeth Pharmaceuticals Inc.

Telecon Date/Time:  02-DEC-2009 07:08 PM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):
Other

Author:  JULIENNE VAILLANCOURT

Telecon Summary:

E-mail: Agenda items for CMC telecon scheduled for December 3, 2009

FDA Participants:   Julie Vaillancourt and Mike Smith

Non-FDA Participants:    Jack Love and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

E-mail:

______________________________________________

From:                     Vaillancourt, Julienne 
Sent:                      Wednesday, December 02, 2009 7:08 PM
To:                          'Love Jack'; 'Devlin Carmel'
Cc:                          Smith, Michael (CBER)
Subject:                Discussion Items for 3 December telecon at 12 noon

Dear Jack and Carmel,

Below are the agenda items for our discussion with you and others from Wyeth tomorrow, December 3, 2009, at 12 noon:

1. Assay and data to confirm conjugate in final drug product:

• In the absence of an assay to measure conjugated polysaccharide in final drug product, what data do you have to support integrity of the conjugate in final drug product throughout the proposed dating period? 
• On September 1, 2009, we requested that prior to licensure you submit data demonstrating the suitability of the -------(b)(4)-------- assay to confirm conjugate in final drug product.  You submitted these data on 10/8/2009.  Our review of these data is ongoing.  To facilitate discussion we are providing you with the attached draft review comments.

2. -------(b)(4)-------- specification for serotype 1.

 

[Attachment]

Julienne Vaillancourt, R.Ph., M.P.H.
Captain, US Public Health Service
Regulatory Reviewer
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
US Food and Drug Administration

Phone:    301-827-5414
Fax:        301-827-3532
E-mail:   julienne.vaillancourt@fda.hhs.gov

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Attachment:

Draft Review of Amendment 0.37 to BLA 125324 (submitted October 8, 2009

Re: Drug Product Stability Indicating Assay (-------(b)(4)----------------------------)

Background

In a tele-conference on June 19, 2009 and subsequent face-to-face meeting between CBER and Wyeth on September 1, 2009, CBER requested that Wyeth develop a test for conjugate on Drug Product that can be used as a stability indicating assay for the final vaccine. CBER and Wyeth agreed that the principle be demonstrated on two pneumococcal conjugates, one being representative of the -----(b)(4)---- and the other being representative of the -----(b)(4)---- conjugation process.

In amendment 0.37 submitted on October 8, 2009, Wyeth submitted studies in support of the -------(b)(4)----------assay performed by -------(b)(4)--------- method as a test for conjugate in Drug Product and also as a stability indicating method for 11 of 13 serotypes based on the data from two representative pneumococcal conjugates. The -------(b)(4)----------- assay             ------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

CBER’s Comments

Based on the information presented in amendments 0.22 and 0.37, there is not enough evidence to demonstrate that the -------(b)(4)------------ method measures only the conjugate in a consistent manner and that this assay could be considered as a stability indicating method. Scientific principle or proof of concept that this method is stability indicating has not been demonstrated.

Part of this may be due to lot to lot variability of -------(b)(4)--------------------------------------------------------, which has not been evaluated by the sponsor. To establish accuracy and precision of the -------(b)(4)-------- method, please evaluate the -------(b)(4)-------------------------------------------------------------------------------------------------by studying a number of lots and a number of final formulations. Based on limited data on consistency -------(b)(4)--------------of different lots of conjugates -------(b)(4)-------------------, the -------(b)(4)---------------method cannot be accepted as a test for conjugate and could not be used a stability indicating method. Detailed comments on various studies submitted by you are given below.

 

1.         -------(b)(4)-----------------------------------------------------------------------------------------------:

a.         -------(b)(4)-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------)

b.         -------(b)(4)----------------------------------------------------------------------------------------------------------------------)

c.         -------(b)(4)----------------------------------------------------------------------------------------------------------------------

d.         -------(b)(4)---------------------------------------------------------.

                                                                       

2 pages determined not to be releasable: (b)(4)