Record of Telephone Conversation - August 7, 2009 - Prevnar 13

System Info - 104141  SMITH, MICHAEL J  02-Sep-2009 17:03:23  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:  07-AUG-2009 02:30 PM               Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):
1. Advice
2. Other

Author:  MARION GRUBER

Telecon Summary:
Extension of review clock & rescheduled VRBPAC meeting

FDA Participants:   Karen Midthun, Norman Baylor and Marion Gruber

Non-FDA Participants:    Jack Love, Emilio Emini and Carmel Devlin

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:

See attached one-page MS Word file.

Record of Teleconference

Date/Time:	August 7, 2009, 2:30 PM
File:	BLA 125324
Product:	Prevnar 13™
Sponsor:	Wyeth Pharmaceuticals Inc.
Subject:	Extension of review clock & rescheduled VRBPAC meeting
Participants:
CBER:	Karen Midthun, MD, Acting Director, CBER Norman Baylor, PhD, Director, CBER/OVRR Marion Gruber, PhD, Acting Deputy Director, CBER/OVRR
Wyeth:	Jack Love, PhD, Assistant Vice President, Global Regulatory Affairs Emilio Emini, PhD, Executive Vice President Carmel Devlin, Director, Global Regulatory Affairs

Background:  On August 6, 2009, the Office of Vaccines Research and Review informed the sponsor about the Agency’s decision to cancel the September 10, 2009, VRBPAC meeting to discuss Prevnar 13, because it considered this meeting to be premature, given outstanding CMC issues identified in the review of the Prevnar 13 BLA to date, in particular, information contained in the July 23rd submission.  The sponsor requested a follow-up meeting with CBER to discuss how to proceed forward.

Discussion Points:

The following were discussed during the present teleconference with the sponsor:

• CBER informed Wyeth that the July 23rd submission would be deemed a major amendment.  Thus, the review clock would be extended by 90 days.  It was agreed that a Major Amendment letter concerning BLA 125324 would be issued by CBER beyond the required 14-day time window of receipt of an amendment to the BLA, i.e., a few days later.
• CBER will work with Wyeth over the next couple of months in an attempt to resolve outstanding CMC issues.   In this regard, CBER agreed to have a face-to-face technical meeting with the sponsor to clarify the outstanding CMC issues and expectations for a path forward.
• CBER informed the sponsor that the VRBPAC meeting to discuss Prevnar 13 would be rescheduled to take place on November 18 or 19, 2009.
• In addition, CBER informed the sponsor that a tentative closed session to discuss outstanding CMC issues would be planned.  CBER noted that if the outstanding CMC issues are resolved prior to the VRBPAC meeting, then the closed session will not take place.