Submission Type: BLA
Submission ID: 125419/0
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
ID Biomedical Corporation of Quebec (dba GlaxoSmithKline Biologicals)
Telecon Date/Time: 06-Dec-2012 12:30 PM Initiated by FDA? Yes
Telephone Number: 610-787-3767
1. Other - Notification of Major Amendment; Agreement of PMR and PMC
Author: Carmen M. Collazo-Custodio
GSK was notified of designation of a submission as a major amendment, thus extending the review clock by 3 months.
FDA Participants: Carmen M. Collazo-Custodio, Marion Gruber
Non-FDA Participants: Donna Boyce, Michael Schwartz, Jillian Horvath
Status Update of STN 125419/0 as of December 5, 2012.
- Two amendments (Amendments # 18 and # 19) were received on Friday, November 30, 2012.
- Amendment # 19 provided responses to Information Requests of November 5, 19, 20 and 29, 2012. Review of this submission generated a response on the Lot Release Protocol (LRP) template that CBER sent to GSK on December 5, 2012. In general, CBER agreed with GSK’s proposal, but the LRP template still needs to be finalized.
- Amendment #18 provided responses to Information Requests of October 17 and November 8, 2012, and included changes to eCTD modules 2 and 3. These changes were made because GSK decided to seek approval only for filling the AS03 final container under ----(b)(4)--------------------- (and to no longer seek approval under the BLA -------(b)(4)---------------------). GSK stated that they are no longer seeking approval for --------------------------------(b)(4)-------------------- of these methods were originally claimed for approval, but GSK has not conducted adequate testing --------------------(b)(4)-). This decision was made in response to previous Information Requests dated September 10, 2012, October 17, 2012, and November 8, 2012. A table was presented to facilitate review of these sections; however, review of these documents will be time consuming.
- GSK provided a table with pending Information Requests containing proposed target dates for submission. There are five pending Information Requests (including one that emerged on December 5, 2012, after a telecon held between CBER and GSK). These Information Requests are related to facilities information. During the conference call held on December 5, 2012, GSK acknowledged that they made several mistakes in the reports provided in the BLA (e.g., missing validation data, discrepancy in dates, incomplete summary reports). These reports were translations of reports originally in French and contained inaccuracies that has made reviewing them difficult.
- CBER has agreed to receive GSK’s responses to these IR’s by e-mail on Friday, December 7, 2012, to expedite the review of this information prior to a formal submission to the BLA (targeted for December 10, 2012).
- Still ongoing is the Labeling review.
- CBER’s review comments on the PI and cartons/container labels were provided to GSK on November 9, 2012.
- GSK submitted a revised PI on December 4, 2012.
- GSK proposed to submit revised cartons/container labels on December 6, 2012.
Dr. Marion Gruber informed GSK of a decision made to designate an amendment received on November 30, 2012, as a major amendment. Dr. Gruber explained that a substantial amount of information was submitted on November 30, 2012, that needs to be adequately reviewed in a limited amount of time, given the Action Due Date of December 22, 2012. In addition, there are still several responses pending to significant Information Requests. The review clock will be extended by 3 months. GSK asked about the possibility of approving the BLA sooner than the 3 months. CBER explained that we will strive to approve earlier, but cannot commit to a particular target date. GSK understood our position.
GSK also asked whether we are still having internal discussions about their proposed Postmarketing Requirement (PMR). GSK proposed to confirm the clinical benefit of Q-Pan H5N1 using seasonal influenza study FLU Q-QIV-006. This is an efficacy study conducted in children 3 to 8 years of age with seasonal quadrivalent unadjuvanted influenza virus vaccine manufactured following the FluLaval (STN:BL 125163) manufacturing process. Dr. Gruber stated that CBER has agreed with their proposal. CBER also agreed with GSK’s proposed Postmarketing Commitment to collaborate with FDA and other U.S. governmental agencies on plans to collect, through government-sponsored studies of Q-Pan H5N1, additional safety and effectiveness data when the vaccine is used during an H5N1 influenza virus pandemic. CBER clarified the latter would be a voluntary, and not a required, postmarketing study.
The teleconference ended.