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Vaccines, Blood & Biologics

PeRC Outcome Email, September 19, 2012 - EVARREST

Tilghman, Tracy

From:     Hornatko-Munoz, Adrienne

Sent:      Wednesday, September 19, 2012 10:33 AM

To:         Tilghman, Tracy

Subject: FW: PeRC Outcome 9/5




From: Buch, Barbara D

Sent: Thursday, September 06, 2012 11:12 AM

To: Hornatko-Munoz, Adrienne; Lindsey, Kimberly; Jain, Nisha; Singh, Ketaki *; Marks, Peter; Maloney, Diane; Yetter, Robert; Vincent, Carla; Michaud, Ginette

Subject: RE: PeRC Outcome 9/5


I would like to add my judos as well. Good job everyone! Barb




From: Hornatko-Munoz, Adrienne

Sent: Thursday, September 06, 2012 11:06 AM

To: Lindsey, Kimberly; Jain, Nisha; Singh, Ketaki *; Buch, Barbara D; Marks, Peter; Maloney, Diane; Yetter, Robert; Vincent, Carla; Michaud, Ginette

Subject: RE: PeRC Outcome 9/5


Thanks to all who had input to the successful PeRC presentation yesterday.  A special thanks to both Drs. Kimberly Lindsey and Nisha Jain for representing OBRR . Dr. Lynne Yao, new Director for PMHS, led the PeRC.


BLA 125392 Fibrin Sealant Patch (Evarrest) was presented.


PeRC agreed with OBRR's recommendation for a partial waiver & deferral as follows:


1)       Partial waiver – pediatric patients birth to 1 month of age (unsafe & ineffective in this age group)

2.)      Partial deferral – pediatric patients  1 month to < 17  years of age

3.)      Pediatric Plan – pediatric patients 1 month to 16 years 11mos


OBRR was asked to comment on two (2) planned EMA studies.  OBRR noted that one of the studies mirrored that which is being conducted in the US, but, the second which compares the standard of care to the fibrin pad to control –b(4)-- bleeding, is outside the scope of the US proposed indication.  This led to a discussion about the pathway for licensing fibrin sealants as a general adjunct to hemostasis versus a primary mode of hemostasis.


PeRC comments/suggestions:


1)  We will be extrapolating efficacy so the planned study is not a true efficacy trial; so recommend rewording the title/description






2)  Define the weight restriction in the protocol since we have some idea of the size of the pediatric patient for whom this would be unsafe


3)  Add language throughout the label (Highlights/Limitations & Use/Indications etc) to explain why it's unsafe in children under 1 month of age.


Thanks- Adrienne




Adrienne Hornatko-Munoz, RAC Consumer Safety Officer

Review Management Staff, Office of the Director


301-827-3092 phone

301-827-9434 fax




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