The Medical Letter on Drugs and Therapeutics
Note: Zolgensma Data Manipulation
Download PDF:   US English
Med Lett Drugs Ther. 2019 Aug 26;61(1579):129
 Select a term to see related articles  nusinersen   onasemnogene abeparvovec   spinal muscular atrophy   Spinraza   zolgensma 

On August 6, 2019, the FDA issued a statement on data manipulation/inaccuracy issues with Zolgensma, a virus vector-based gene therapy approved for one-time IV treatment of children <2 years old with spinal muscular atrophy.1 We reviewed Zolgensma in our July 29 issue.2 According to the FDA statement, the manipulated data pertained to the production process for the product and did not affect the efficacy or safety results from the human clinical trials. It does not require any change in our review.

© The Medical Letter, Inc. All Rights Reserved.
The Medical Letter, Inc. does not warrant that all the material in this publication is accurate and complete in every respect. The Medical Letter, Inc. and its editors shall not be held responsible for any damage resulting from any error, inaccuracy, or omission.
This article has been freely provided.
arrow to previous article
arrow to next article