
Telecon - Advice, June 11, 2009 - Menveo


 

 
System Info - 96614  SHONE, DEANNA   12-Jun-2009 15:26:35  SHONEDE

RECORD OF TELEPHONE CONVERSATION

 

Submission Type: Original Application   Submission ID:  125300/0    Office: OVRR  

Product:
 Meningococcal ACWY Conjugate Vaccine

Applicant:                                                                        
 Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  11-JUN-2009 12:00 AM               Initiated by FDA?  Yes
 Telephone Number:    

Communication Categorie(s):
 Advice

Author:  CARA FIORE

Telecon Summary:


FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

  
 Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Webster, Christopher [mailto:christopher.webster@novartis.com]
Sent: Friday, June 12, 2009 6:32 AM
To: Fiore, Cara
Subject: RE: Novartis Vaccines: BLA 125300 - Finalization of review
 Dear Cara,

No, P13E1 is the persistence of antibody to the meningococcal polysaccharides through 2 years post-primary vaccination.  The Gardasil data are in V59P18, which you have.  P13E1 will be submitted to the BLA, but we would not like it to delay licensure - we will seek a label change post-licensure.

Best,
 Chris

Chris Webster
Head, Regulatory Affairs, Meningitis
Novartis Vaccines and Diagnostics
Direct: (617) 871-4280
Cell: (617) 417-9583
Email: christopher.webster@novartis.com


From: Fiore, Cara [mailto:Cara.Fiore@fda.hhs.gov]
Sent: Thursday, June 11, 2009 4:30 PM
To: Webster, Christopher
Subject: RE: Novartis Vaccines: BLA 125300 - Finalization of review
 for my own clarification - P13E1 CSR submission is for this BLA?  This contains the Gardasil data?


From: Webster, Christopher [mailto:christopher.webster@novartis.com]
Sent: Thursday, June 11, 2009 4:19 PM
To: Fiore, Cara
Cc: Valenti, Elizabeth
Subject: RE: Novartis Vaccines: BLA 125300 - Finalization of review
 Thanks, Cara - I'm staying tuned.

Chris

Chris Webster
Head, Regulatory Affairs, Meningitis
Novartis Vaccines and Diagnostics
Direct: (617) 871-4280
Cell: (617) 417-9583
Email: christopher.webster@novartis.com


From: Fiore, Cara [mailto:Cara.Fiore@fda.hhs.gov]
Sent: Thursday, June 11, 2009 4:11 PM
To: Webster, Christopher
Cc: Valenti, Elizabeth
Subject: RE: Novartis Vaccines: BLA 125300 - Finalization of review
 Hi Chris, I spoke with Willie earlier and no word yet, sorry  we had hoped to be able to by now.  I will forward the below info to our reviewers.
 Thanks,
 Cara


From: Webster, Christopher [mailto:christopher.webster@novartis.com]
Sent: Thursday, June 11, 2009 10:16 AM
To: Fiore, Cara
Cc: Valenti, Elizabeth
Subject: RE: Novartis Vaccines: BLA 125300 - Finalization of review
 Dear Cara,

Just checking-in - I wonder whether you can give me any information now on the procedure for finalizing the review (first point below).

Also, on the interim CSR for V59P13E1, we now expect to submit this in mid-July (I apologise, I was given erroneous dates for my earlier communication).

Best,
 Chris
Chris Webster
Head, Regulatory Affairs, Meningitis
Novartis Vaccines and Diagnostics
Direct: (617) 871-4280
Cell: (617) 417-9583
Email: christopher.webster@novartis.com


From: Fiore, Cara [mailto:Cara.Fiore@fda.hhs.gov]
Sent: Tuesday, June 02, 2009 6:38 PM
To: Webster, Christopher
Cc: Valenti, Elizabeth
Subject: RE: Novartis Vaccines: BLA 125300 - Finalization of review
 Hi Chris,
 please see, embedded below, our preliminary answers.


From: Webster, Christopher [mailto:christopher.webster@novartis.com]
Sent: Tuesday, June 02, 2009 9:27 AM
To: Fiore, Cara
Cc: Valenti, Elizabeth
Subject: Novartis Vaccines: BLA 125300 - Finalization of review

Dear Cara,

As we enter the final 30 days of the primary cycle of the BLA review, I would like to summarize our understanding of the steps that must be completed before the action date.  At this time, I would also like to ask whether you can let me know procedurally how CBER intends to deal with the review of the amendments that we are submitting during June (i.e., would this be by extension of the current review cycle or by issuance of a CR letter, with review in a second cycle?)  This question is based upon Dr Vann's statement, during our teleconference on 23 March, that CBER would have this determination by "early June"; and we understood that you would be able to let us know in advance of the action letter.  Naturally, this is of enormous interest within the company.

We still expect to be able to determine this by early to mid June.

The following are the BLA submissions that are pending now, and that will be completed before the action date:
•Submission of a protocol for a postmarketing pharmacovigilance safety study.
•Submission of a package on revalidation of alert limits for --b(4)------ during the steps of polysaccharide --b(4)--- together with data from manufacture of b(4) lots of each polysaccharide.
•Submission of responses to your IR on the new filling line, -b(4)-.

In addition, as mentioned to you last week, we expect to have a study report on V59P13E1 by mid-June.  This will give the persistency of circulating antibody through 2 years after primary vaccinations in adolescents.  Also, as we discussed on the call with Dr Bash on 9 April, you have data in the BLA on interference with HPV (Gardasil) from V59P18.  Please advise whether it will be possible to review one or both of these during the extension of the review period (whatever the procedure for this) so that they could be included in the label, or whether we should consider them as post-licensure amendments.  We would not wish the review of these items to extend the review any longer than will already be the case for the submissions listed above. 

We will let you know this after we have the V50P13E1 study report in hand and given it a preliminary look over. At this point, as requested by you at the above telecon, we will not review the Gardasil data from V59P18.

Finally, an important step still to be accomplished is the adjustment of the package insert and approval of the packaging.  Because of the extended lead times for printing prior to launch, please would you let me know when we should expect these. 

Package insert finalization occurs at the time of Action Due Date. 

I hope that this summary is helpful; please let me know if you have questions or feel I have missed anything.

Best,
 Chris
Chris Webster
Head, Regulatory Affairs, Meningitis
Novartis Vaccines and Diagnostics
Direct: (617) 871-4280
Cell: (617) 417-9583
Email: christopher.webster@novartis.com
