
Information Request Email, Risk Management Plan, December 31, 2014 - BEXSERO
 

 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125546/0     Office: OVRR

Product:
 Meningococcal Group B Vaccine

Applicant:
 Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 31-Dec-2014 3:46 PM     Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s): 
 1. Information Request

Author: RAMACHANDRA NAIK

Telecon Summary: IR regarding Risk Management Plan

FDA Participants: RAMACHANDRA NAIK, ED WOLFGANG AND KIRK PRUTZMAN

Non-FDA Participants: SUE FEKETE

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
 E-mail and attached document attached.


From: Naik, Ramachandra
 To: "Fekete, Sue"
 Cc: "Stoehr, Patricia"; Prutzman, Kirk C; Wolfgang, Edward
 Subject: STN 125546 - Information Request on Risk Management Plan
 Date: Wednesday, December 31, 2014 3:46:00 PM
 Attachments: STN 125546-0 IR regarding Risk Management Plan.pdf

Dear Ms. Fekete:

Please find attached a request for additional information regarding STN 125546 (Meningococcal Group B Vaccine). Please provide your responses to this information request in an Amendment to STN 125546 by January 7, 2015. If you have any questions about this communication, please contact Ramachandra Naik, Ed Wolfgang or Kirk Prutzman at (301) 796-2640.

Regards,
 Ramachandra S Naik, PhD
 Primary Reviewer
 Food and Drug Administration
 CBER/OVRR/DVRPA/RRB3
 HFM-475
 10903 New Hampshire Avenue
 Building 71, Room 3045
 Silver Spring, MD 20993
 Phone: (301) 796-2640
 FAX: (301) 59


CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
 OFFICE OF VACCINES RESEARCH AND REVIEW
 DIVISION OF VACCINES AND RELATED PRODUCTS APPLICATIONS

DATE: DECEMBER 31, 2014       PAGES: 2

TO: NOVARTIS VACCINES AND DIAGNOSTICS, INC

ATTENTION: PATRICIA STOEHR, PH.D.
 Senior Group Manager, Regulatory Affairs
 350 Massachusetts Avenue, Cambridge, MA 02139 USA
 FAX: (617) 871-4711     TEL: (617) 871-8060

FROM: RAMACHANDRA S. NAIK, PH.D.
 Regulatory Project Manager
 FAX: (301) 595-1244 TEL: (301) 796-2640

SUBJECT: STN: BL 125546/0 – Request For Information

MESSAGE:

Dear Dr. Stoehr: 

We have the following request for additional information regarding your submission of Biologics License Application STN 125546 (Meningococcal Group B Vaccine):

The following comment pertains to the Risk Management Plan (version 5) located in module 1.16 of the BLA.

On page 45 of 136, section 6 “Part II Safety Specification Module SV: Post-authorization experience”, you state the following:

“However, it has been launched very recently in 5 countries at the end of November 2013 with very limited number of dose until the end of 2013 --(b)(4)-- doses distributed in UK, Ireland, Germany, France and Italy). The number of doses sold between the launch and the data lock point of this RMP are evaluated to (b)(4).”

Yet, in section 6.2, you state “The numbers of doses sold in the five countries up to the 13th of January 2014 were -(b)(4)--.”
1.Please clarify the actual number of doses distributed for the 5 European countries, Canada, Australia and any other countries in which BEXSERO is licensed, from the international birth date to the data lock point for this RMP.
2.Please clarify the discrepancy between section 6 which states (b)(4) doses sold and section 6.2 which states (b)(4) doses sold in the five EU countries (page 45).
3.Are the number of doses sold estimates? If so, please briefly describe how these numbers were obtained from the number of doses distributed. 

Please provide your responses to this information request in an Amendment to STN 125546 by January 7, 2015. We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference. If you have any questions about this communication, please contact Ramachandra Naik, Ed Wolfgang or Kirk Prutzman at (301) 796-2640.
