August 6, 2019 / 5:25 PM / 3 months ago

BRIEF-U.S. FDA Was Informed By Avexis Product's Manufacturer, About A Data Manipulation Issue

Aug 6 (Reuters) - U.S. FDA

* STATEMENT BY PETER MARKS, M.D., PH.D., DIRECTOR OF FDA’S CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, ON DATA ACCURACY ISSUES WITH RECENTLY APPROVED GENE THERAPY

* U.S. FDA SAYS IT IS CRITICAL TO FACILITATE DEVELOPMENT OF SAFE, EFFECTIVE MEDICAL PRODUCTS, LIKE CELLULAR, GENE THERAPY PRODUCTS THAT HAVE POTENTIAL

* U.S. FDA SAYS ON JUNE 28, FOLLOWING FDA’S APPROVAL OF PRODUCT, AGENCY WAS INFORMED BY AVEXIS PRODUCT’S MANUFACTURER, ABOUT A DATA MANIPULATION ISSUE

* U.S. FDA - DATA MANIPULATION ON AVEXIS PRODUCT’S IMPACTS ACCURACY OF SOME DATA FROM PRODUCT TESTING PERFORMED IN ANIMALS SUBMITTED IN BLA & REVIEWED BY FDA

* U.S. FDA SAYS IS CAREFULLY ASSESSING SITUATION & REMAINS CONFIDENT THAT ZOLGENSMA SHOULD REMAIN ON MARKET

* U.S. FDA SAYS CONCERNS ARE LIMITED TO ONLY A SMALL PORTION OF PRODUCT TESTING DATA THAT WAS CONTAINED IN MARKETING APPLICATION FOR ZOLGENSMA

* U.S. FDA - DATA DO NOT CHANGE ASSESSMENT OF INFORMATION FROM HUMAN CLINICAL TRIALS THAT WERE CONDUCTED AS PART OF ZOLGENSMA’S DEVELOPMENT PROGRAM

* U.S. FDA SAYS INTEGRITY OF PRODUCT TESTING DATA USED IN DEVELOPMENT OF PRODUCT’S MANUFACTURING PROCESS FOR ZOLGENSMA IS BEING EVALUATED

* U.S. FDA SAYS AWARE THAT AVEXIS BECAME AWARE OF ISSUE OF DATA MANIPULATION THAT CREATED INACCURACIES IN THEIR BLA BEFORE FDA APPROVED PRODUCT

* U.S. FDA SAYS AWARE THAT AVEXIS BECAME AWARE OF DATA MANIPULATION THAT CREATED INACCURACIES, YET DID NOT INFORM FDA UNTIL AFTER PRODUCT WAS APPROVED

* U.S. FDA SAYS AGENCY WILL USE FULL AUTHORITIES TO TAKE ACTION, WHICH MAY INCLUDE CIVIL OR CRIMINAL PENALTIES FOR AVEXIS’ DATA MANIPULATION ISSUE

* U.S. FDA SAYS IS CAREFULLY ASSESSING ISSUE OF MANIPULATION OF PRODUCT TESTING DATA USED IN PRODUCTION PROCESS

* U.S. FDA SAYS CONDUCTING A THOROUGH ASSESSMENT OF INFORMATION FROM A RECENTLY COMPLETED INSPECTION Source text for Eikon: Further company coverage:

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