Novartis’ Zolgensma Had Manipulated Data In Application, US FDA Says
Novartis’ Zolgensma Had Manipulated Data In Application, US FDA Says
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The gene therapy Zolgensma will remain on the market, but Novartis and subsidiary AveXis Inc. may face civil or criminal action after revelations by the FDA that data used for approval had been manipulated. In fact, the drug giant knew about the problem months before Zolgensma was approved and said nothing. Learn what happened, why the FDA still asserts confidence in its approval of Zolgensma, and what these events could mean to Novartis and the gene therapy industry moving forward.
Author: Informa Pharma Intelligence
Publisher: Pinksheet
- Description
The gene therapy Zolgensma will remain on the market, but Novartis and subsidiary AveXis Inc. could face civil or criminal penalties after revelations by the US Food and Drug Administration that data used for approval had been manipulated and Novartis knew about the problem months before and did not disclose it, probably fearing delays or worse. How could this have happened, why does the FDA maintain confidence in Zolgensma’s efficacy and safety, and will the Agency do things differently moving forward as a result?
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