Confirmation of RAGWITEK Pediatric PMR Email, April 09, 2014 - RAGWITEK

From: Valenti, Elizabeth
Sent: Wednesday, April 09, 2014 4:25 PM
To: Scott Greenfeder Ph. D. (scott.greenfeder@merck.com)
Cc: Rivers, Katie; Valenti, Elizabeth
Subject: Confirmation of RAGWITEK Pediatric PMR

Dear Scott,

Please confirm Merck’s concurrence with the following pediatric PMR studies:

Deferred pediatric study under PREA to evaluate safety and efficacy of RAGWITEK immunotherapy of short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen specific IgE antibodies for short ragweed pollen in pediatric subjects aged 5 to 17 years.

Final Protocol Submission: December 31, 2014

Study Completion Date: December 31, 2018

Final Report Submission: September 30, 2019

Deferred pediatric study under PREA to evaluate safety of RAGWITEK immunotherapy of short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen specific IgE antibodies for short ragweed pollen in pediatric subjects aged 5 to 17 years.

Final Protocol Submission: June 30, 2016

Study Completion Date: September 30, 2017

Final Report Submission: September 30, 2019

Thank you, Betsy

Elizabeth J. Valenti, MPH, RAC (U.S.), REHS/RS
 CDR, USPHS
 Regulatory Project Manager
 FDA/CBER/OVRR/DVRPA
 1401 Rockville Pike
 Mailstop HFM-481
 Rockville, MD 20852
 (301) 796-2640
elizabeth.valenti@fda.hhs.gov

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