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Activity Number: 680
Type: Topic Contributed
Date/Time: Thursday, August 13, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #315817
Title: The Influence of Clinically and Statistically Meaningful Differences in Risk Benefit: A Case Study of the First Approved Allergenic Sublingual Immunotherapy (SLIT) Products
Author(s): Tammy Massie*
Companies:
Keywords: Sublingual Immunotherapy ; Case Study ; Benefit/Risk ; Allergenic Products ; Advisory Committee ; Safety and Efficacy
Abstract:

In 2014 three novel allergenic sublingual immunotherapy(SLIT) products were approved for the treatment of grass or ragweed pollen induced allergic rhinitis. These approvals were a result of interaction among stakeholders and FDA review team who identified potential benefits and risks of these allergenic SLIT products and developed a path forward. Agency statisticians worked closely with the multidisciplinary review team developing criteria for efficacy to ensure an acceptable benefit-risk profile.

In 2011, to formalize a mechanism for approvals, FDA led Allergenic Product Advisory Committee (APAC) discussions identifying criteria for the safety and effectiveness of SLIT products. These discussions included explicit criteria for efficacy based on clinically meaningful difference in treatment effects as well as safety endpoints.

This presentation will focus on the evolution of the benefit-risk assessment approaches in the licensure process including steps taken during the review of the allergenic products and creation of a more formalized development and adoption of structured benefit-risk assessment approach as part of PDUFA V.


Authors who are presenting talks have a * after their name.

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