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Vaccines, Blood & Biologics

Minutes of Internal Meeting, November 23, 2009 - Flublok


Meeting Date:                       November 23, 2009
Meeting Time:                       1 – 2 PM
Meeting Location:                 Woodmont Office Complex, Conference Room 300N
File:                                        BLA 125285
Product Name:                       Flublok
Sponsor:                                 Protein Science Corporation (PSC)
FDA Attendees:
Norman Baylor, Marion Gruber, Theresa Finn, Wellington Sun, Loris McVittie, Philip Krause, Cynthia Nolletti, Lewis Schrager, Douglas Pratt, Barbara Krasnicka, Tsai-Lien Lin, Sang Ahnn, Maryna Eichelberger, Matthew Sandbulte, Jerry Weir, Deborah Trout, Rakesh Pandey, Katherine Matrakas, Timothy Fritz
Purpose of Meeting:
To determine the impact of the November 19, 2009 VRBPAC on the review of PSC’s FluBlok BLA 125285.
The discussion focused on what type of approval, if any, could be granted for FluBlok. Two types of approval were discussed; traditional versus accelerated.
  • Based upon the VRBPAC vote of 9 to 2 in favor of FluBlok’s efficacy in adults 18-49 years of age, it was felt that traditional approval may be possible for this age group. An efficacy supplement could be submitted by PSC to support licensure in other age groups.
  • It was felt that, based upon the immunogenicity data, accelerated approval may be possible in adults 18-64 years old. A Post Marketing Commitment would be needed for traditional licensure.
  • It was noted that the FDA guidance for accelerated approval required that a product’s safety data should stand on its own. This was a concern given the VRBPAC vote of 6 to 5 against the FluBlok safety data.
Regardless of the type of approval, if any, granted, it was agreed that PSC needed to resolve its outstanding manufacturing issues. The possibility was raised that the remaining manufacturing concerns may be of sufficient extent to warrant a Complete Response letter.

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