
Record of Telephone Conversation, February 6, 2013 - Q-Pan


 
 


Submission Type: BLA


Submission ID: 125419/0


Office: OVRR


 Product: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Applicant: ID Biomedical Corporation of Quebec

Telecon Date/Time: 06-Feb-2013 01:00 PM Initiated by FDA? Yes

Telephone Number: 857-207-4197

Communication Categories:
 1. Information Request
 2. Advice

Author: Jeremy Wally

Telecon Summary: Discussion of Narcolepsy

FDA Participants: Carmen Collazo-Custodio, Kirk Prutzman, Jeremy Wally, Elizabeth Sutkowski, Andrea James, Lewis Schrager, Douglas Pratt, Loris McVittie, Wellington Sun, Theresa Finn, Karen Farizo, Philip Krause, Marion Gruber, Yandong Qiang

Non-FDA Participants: Anne Schuind, David Vaughn, Dominique Barbeau, Donna Boyce, Jillian Horvath, Mike Schwartz, Patricia Izurieta, Wenjun Jiang

Telecon Body:
 The following issues were discussed:

•CBER noted that we are in an information gathering phase regarding the reports of narcolepsy associated with the use of Pandemrix and Arepanrix. CBER asked GSK if the listing of studies being conducted to investigate the association between Pandemrix and narcolepsy submitted to BB-IND 13413 on November 9, 2012, is comprehensive, or if any new studies are planned. GSK stated that the list submitted to the IND appears to be complete and noted that the list of planned completion dates for these studies was included in the submission. CBER also acknowledged the submission of January 7, 2013, to BB-IND 13413 that provided the report of an epidemiological study conducted in Quebec as well as progress reports on two non-clinical studies.
•CBER asked if GSK is aware of any other studies not being sponsored by GSK and GSK listed: (1) a study being conducted in Germany that was discontinued, (2) a study done by HPA for which there is a published abstract only, and (3) the VAESCO study for which a report has already been submitted to the Type V Master File (14234) on May 31, 2012. GSK further stated that they would provide CBER with a copy of the HPA abstract and would go back to their team to determine if there are any other non-GSK sponsored studies of which they are aware. CBER requested that GSK provide a listing of GSK-sponsored and non-GSK sponsored studies to the BLA.
•CBER asked if the pediatric plan proposed in the EMA has been impacted by the recent information regarding narcolepsy. GSK responded that the plan has not been impacted; however, GSK has requested delaying the start of one study (D-051). GSK mentioned two ongoing studies: study D-032, conducted in children 3-17 years old; and study D-013, conducted in children 6-36 months of age. GSK has requested deferring the initiation of a third study, D-051 (to be conducted in infants 2-6 months of age). The reason for this delay is because GSK plans to use the data accrued from the Q-Pan studies planned in the US to inform the design and dosing of study D-051. GSK stated that studies D-032, D-013, and D-051 are being used to support the Pumarix (Q-Pan H5N1) pediatric program approved by the EMA.
•CBER asked if GSK is ready to proceed with the studies outlined in the pediatric plan for the Q-Pan H5N1 vaccine in the US. GSK stated that their plan is to proceed with the proposed pediatric studies and have just submitted a proposal to BARDA for funding.
•CBER asked if GSK has considered modifying the planned pediatric protocols to exclude subjects expressing the DQB1*0602 HLA allele associated with narcolepsy. GSK stated that this screening was considered in internal discussions, -----b(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- CBER stated that if the pediatric supplemental indication was approved, this exclusion may not preclude approval in all children. The pediatric indication to be included in the Prescribing Information would be a separate discussion and would be based on the conclusions of the narcolepsy studies in the coming years. CBER further stated that this is an issue of concern and encouraged GSK to seriously consider this recommendation as they plan the pediatric studies. GSK agreed to evaluate having this exclusion in the planned protocols and to get back to CBER on this issue within 2 weeks. If GSK agrees to exclude children with the narcolepsy-associated HLA allele and this changes the timelines for the pediatric studies, CBER recommended that GSK submit to the BLA an updated table in the pediatric plan (Ongoing and Planned Pediatric Studies for Q-Pan H5N1) with revised timelines. CBER stated that we do not anticipate going back to present the pediatric plan to the Pediatric Review Committee.

 
