System Info - 107223 MCWATTERS, BERNARD 07-Oct-2009 16:58:21 MCWATTERS
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125297/0 Office: OVRR
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 27-AUG-2009 12:00 AM
Initiated by FDA? Yes
Author: BERNARD MCWATTERS
Informed Novartis that they still had deficiencies in their pediatric study design and what they need to do to fix them. Also suggested that we meet on this subject.
FDA Participants: Bernard McWatters
Non-FDA Participants: Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Dr Baylor has the following comments about your protocol that was submitted on August 19 and was supposed to be presented to the PeRC yesterday, August 26. Because of the continued following deficiencies, the PeRC was rescheduled for September 23. I would like to schedule another meeting to include Dr Baylor and the people on your team who are directly responsible for designing the protocols and providing the information that we are requesting. I feel that there is something being lost in communication between us and this is now becoming critical. I will let you know when we can have this meeting. I am going to press to have it as soon as possible.
- We need a post-marketing commitment from you that you will submit the results from Study V71P7 to support the use of Agriflu in children from 4 years of age and older.
On review of the protocol we included the following comment:
You plan to enroll children three years and older in this study. However, the active comparator (Fluvirin) is licensed for use in children four years of age and older. The active control used in the study should be one licensed for use in the children of the ages that are being studied.
- We strongly recommend that you study a 0.25 mL and a 0.5 mL dose of Agrippal in children from 6 months to 35 months of age. This age group can be studied with an active comparator for children 6 months of age and older.
- If you do use Fluvirin as an active control, limit enrollment to subjects four years of age and older.
Because of this, we expect the results of Study V71P7 to support the use of Agriflu in children 4 -17 years only.
If for some reason, the results of this study are not appropriate to support a sBLA for use of Agriflu in children, please propose a study for this age group.
- Please submit a development plan only for subjects from 6 months to 4 years of age.
- Please submit a PMC for the study described in the pediatric development plan (e.g., the study in 6 months to 4 years).
Bernard J.P. McWatters, Ph.D.
1401 Rockville Pike rm. 379N
Rockville, MD 20852
Office - 301-827-3921