
Cancellation of Late Cycle Review Meeting, January 21, 2015 - BEXSERO
 

 
DATE:  January 21, 2015

FROM:  Marion. F. Gruber, Ph.D., Director
 Office of Vaccines Research & Review (OVRR)
 Center for Biologics Evaluation and Research (CBER)
 Food and Drug Administration (FDA) 

TO:  Biologics License Application Submission Tracking Number # 125546/0

PRODUCT:  BEXSERO, Meningococcal Group B Vaccine

SUBJECT:  Request from Novartis Vaccines and Diagnostics, Inc. for cancellation of Late Cycle Review Meeting

THROUGH:   Margaret Bash, M.D., M.P.H. 
 Chair, STN 125546/0 BLA Review Committee
 Division of Bacterial, Parasitic and Allergenic Products (DBPAP), OVRR

CC:  Kirk Prutzman, Ph.D.

APPLICANT:   Novartis Vaccines and Diagnostics, Inc.

This serogroup B meningococcal vaccine was designated breakthrough therapy and the STN 125546/0 BLA was given “priority review.” Because of the public health importance of this vaccine, CBER worked closely with the applicant to be able to complete the review of this BLA in an expedited manner.

Novartis has responded adequately to information requests from CBER regarding this BLA. A few minor review issues remain, but I expect these issues to be resolved in a timely manner. Additionally, minor labeling issues remain, but these are also expected to be rapidly addressed. There are no major review issues outstanding. During the Mid-Cycle Communication on November 21, 2014, the applicant was informed that CBER has not identified any major issues and/or safety concerns that would affect the completion of the review of this BLA. 

In an e-mail sent to me on January 21, 2015, Manish Vyas of Novartis noted that final label negotiations and a few remaining review items are actively being discussed between the agency and Novartis, and these are expected to close shortly. Thus, Novartis requested that the proposed January 23, 2015, Late Cycle Review meeting be cancelled. I informed Novartis on January 21, 2015, by e-mail, that CBER will cancel the Late-Cycle Review Meeting. 

See e-mail chain below on this matter: 


From: Gruber, Marion
 To: "Vyas, Manish"
 Cc: Prutzman, Kirk C
 Subject: RE: Bexsero BLA/ Request for Cancellation of Late Cycle Review meeting
 Date: Wednesday, January 21, 2015 5:15:00 PM

Dear Manish,

We agree that a Late Cycle Review meeting is not necessary and will cancel that meeting.

Sincerely,
 Marion Gruber

From: Vyas, Manish [mailto:manish.vyas@novartis.com]
 Sent: Wednesday, January 21, 2015 4:23 PM
 To: Gruber, Marion
 Subject: Bexsero BLA/ Request for Cancellation of Late Cycle Review meeting

Dear Marion, 

As discussed during a call between Dr. Kirk Prutzman from CBER and Dr. Patricia Stoehr from Novartis this morning, Novartis understands that review of our BLA STN 125546 is nearing completion and there have been no major issues or safety concerns identified that would affect approval of the BLA. All responses to CBER’s Information Requests have been submitted and final label negotiation is expected to be completed within the next days. There are very few remaining items that are actively being discussed between the agency and Novartis and these are expected to close shortly. Considering that there are no major issues requiring further discussion, Novartis Vaccines requests that the proposed January 23, 2015 Late Cycle Review meeting be cancelled. Please contact me with any questions at the number below. 

Sincerely,
 Manish Vyas

VP, Global Head, Regulatory Affairs
 Novartis Vaccines & Diagnostics
 350 Massachusetts Avenue
 Cambridge, MA 02139
 Office/cell: 617 852 3848 
