Submission Type: BLA Submission ID: 125363/0 Office: OVRR Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 30-Nov-2011 04:30 PM Initiated by FDA? Yes
Telephone Number: -----(b)(4)-------
Author: JOSEPH TEMENAK Telecon Summary:
Advice to GSK that they should submit their diluent/manufacture change in a PAS, NOT along with their CR response (planned for 11-30-2011). FDA/GSK agreed that GSK could submit the diluent info. (11-30-2011). but that FDA will not review it.
FDA Participants: Joseph Temenak, Elizabeth Sutkowski
Non-FDA Participants: GSK – Jody Gould, and Barbara Howe
Trans-BLA Group: No
Related STNs: Hiberix (125347)
Related PMCs: (PAS) STN 125347/(b)(4) (Hiberix) Telecon Body:
We contacted GSK to communicate advice about their planned CR response submission. On 11-25-2011, GSK stated that along with their CR response they would be including a diluent/manufacture change to MenHibrix as well. This change is very similar to a PAS that GSK submitted on 11-21-2011 to Hiberix. We had agreement among all the potential review divisions in FDA: DVRPA, DMPQ, and DBPAP that only the CR response should be included in the submission planned for 11-30-2011, NOT the diluent/manufacture change. In addition, all the review divisions agreed that the diluent/manufacture change should be submitted post-licensure, i.e., similar to the PAS GSK submitted for Hiberix.
We communicated our position to GSK that they should submit the CR response 11-30-
2011 as planned, but to remove the diluent/manufacture change and wait until post- licensure to submit that to the file as a PAS. GSK proposed they submit the information so that FDA could have the opportunity to possible review it within the CR response clock (6 months), and that it would depend on how the review of the Hiberix PAS was progressing. We didn’t think that option fit with all the review divisions’ advice and again suggested that the diluent/manufacture change must be handled post-licensure of MenHibrix.
GSK stated that they have the electronic submission ready to go, i.e., just to push the button and send it across the FDA gateway. They stated that to remove the diluent/manufacture information from the submission would set them back in time maybe a week or more, so they asked if they could just submit the response as is – including the diluent/manufacture change. We agreed to accept the submission containing the diluent/manufacture change for MenHibrix in their submission (11-30-2011), but stated emphatically that we would NOT review this information prior to licensure of MenHibrix. In addition, we asked GSK to submit an amendment to their CR response as soon as possible, stating that they understand FDA allowed the diluent/manufacture changes to be included in their submission, but that GSK agrees, and understands that FDA will NOT review this information pre-licensure.