Consumer Industry Reports

FDA Says Zolgensma Data Was Manipulated By Novartis AG


The U.S. Food and Drug Administration (FDA) stated that while seeking approval for Zolgensma, Novartis AG—a Swiss drugmaker—had manipulated data. Shortly after the agency’s this announcement, there was a drop in the shares of the Swiss drugmaker this week. Zolgensma is known as “the priciest drug in the world” that is employed in the treatment of children with spinal muscular atrophy (SMA). The latest situation has pushed drug makers—which are mostly in the news for suspected data integrity violations—back into the spotlight.

The FDA highlighted that on March 14, 2019, Novartis AG was aware of this issue. It added that the firm did not notify the regulator for more than a month regarding the data issue. Consequently, the drug was approved by the agency on May 24, 2019.

Zolgensma—with a price tag of approximately $2.1 Million—is a life-saving treatment for infants. It is considered as the foremost gene therapy for a critical type of SMA. In April 2018, Novartis got hold of this therapy, which was initially developed by AveXis. While FDA continues the examination of data, it has also warned of taking legal action against Novartis AG. In a statement, the regulator asserted that the FDA is considering if there is a need for further action—which can be “criminal or civil penalties.”

On a similar note, recently XyloCor Therapeutics stated that Rickey Reinhardt will work as its new CMO. Earlier, Reinhardt had assisted GlaxoSmithKline to introduce a gene therapy in the market. At XyloCor, he will be involved in taking genetic treatments for cardiovascular diseases by means of clinical development. Late last year, XyloCor set itself up to move a gene therapy treatment for treatment-resistant angina into clinical development. At the same time, the firm was also engaged in raising approximately $17 Million in a Series A round—which was co-led by Sofinnova Partners and LSP.

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