Date: Monday, March 23, 2009, 1100 EDT
To: The File
From: Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Point of Contact: LT Elizabeth J. Valenti, REHS
Regulatory Program Manager
Subject: Teleconference Memo
Product: Menveo, Meningococcal ACWY Conjugate Vaccine
Sponsor: Novartis Vaccines and Diagnostics, Inc.
Summary: Discussion Regarding Process Validation Required Prior to Licensure
Milan Blake, Ph.D., Director, OVRR/DBPAP
Cara Fiore, Ph.D., Regulatory Program Manager, OVRR/DVRPA
Joseph George, OCBQ/DMPQ
Marion Gruber, Ph.D., Acting Deputy Director/Associate Directory for Reg. Policy, OVRR
Wellington Sun, M.D., Director, OVRR/DVRPA
Elizabeth Sutkowski, Ph.D., Chief, Review Branch III, OVRR/DVRPA
Nicole Trudel, OCBQ/DMPQ
LT Elizabeth Valenti, REHS, Regulatory Program Manager, OVRR/DVRPA
Willie Vann, Ph.D., Chief, Laboratory of Bacterial Polysaccharides, OVRR, DBPAP
During Novartis’s API, February 18-27, 2009, one of three process validation lots, Lot #b(4), failed to meet --b(4)--------- acceptance criteria. To rectify the process Novartis proposed:
- Correcting the MenW serotype, and submitting the process validation, assay, and data to the BLA prior to March 31, 2009.
- Submitting a CBE-30 for the process validation, assay, and data for the correction of the A, C, and Y serotypes after licensure.
Prior to the telecon Novartis submitted a PowerPoint presentation (attached) containing an update on the MenW inactivation validation.
Dr. Vann explained to Novartis that their proposal was discussed with the review committee and management. CBER’s decision is that the product cannot be licensed without complete validation. All four serotypes must be validated prior to licensure, not as CBE-30 supplements.
Novartis explained that they expected to be able to submit the MenW data during the first week of April, and requested clarification regarding how submission of all four serotypes would affect the review timeline. Novartis further explained that they expected to be able to submit the process validation and assay information for all four serotypes in the beginning of June.
CBER requested that Novartis submit complete information for process validation, assay information, and data for all four serotypes at one time. Submission at the beginning of June would be too close to the action due date, June 29, 2009, however CBER has not yet completed review of the rest of the BLA submission and therefore cannot determine how long the review clock would be extended. CBER explained that although a major amendment extends the review clock by 90-days, review of the Menveo BLA was still ongoing. Other regulatory action may be taken based upon the outcome of all pending reviews.
Novartis informed CBER that they were prepared to submit the corrections to the Laboratory Information Management System (LIMS) in a few days and CBER stated that submission of the amendment was appropriate.
Novartis asked if CBER still wanted Novartis to present their PowerPoint presentation. Dr. Vann explained that CBER reviewed Novartis’s PowerPoint and had no specific comments; therefore it was not necessary for Novartis to present the slides.
Novartis inquired as to whether their --b(4)--------- site would be inspected. Mr. George informed Novartis that he has recommended a waiver for that facility however the waiver was still pending.
Novartis concluded the call by stating they would submit data for all four serotypes at once and they hope to have all of the information submitted by June.