The Food and Drug Administration has taken interest in the amount of time that Swiss drugmaker Novartis took between finding out about a data manipulation issue concerning its   gene therapy and launching a formal inquiry into the matter, according to a news report.

The agency is looking at the two-month delay between Novartis’ discovery of the data manipulation issue – concerning the therapy Zolgensma (onasemnogene abeparvovec-xioi) – and its launch of a formal probe, according to The Wall Street Journal.

According to an FDA report reviewed by the newspaper, the company did not open a formal inquiry until May 15, despite becoming aware of the issue on March 14, and it did not provide an explanation for the gap. Zolgensma was approved for spinal muscular atrophy in infants on May 24 and is the highest-priced drug ever, with a list price of $2.1 million.

The ongoing scandal erupted on Aug. 6, when the FDA said that AveXis, the Novartis unit that developed Zolgensma and that the drugmaker acquired last April for $8.7 billion, knew about the issue, but did not inform the agency until late June. The manipulated data were related to a preclinical test that is no longer used and thus do not affect the approved version of Zolgensma, which the FDA has said should remain on the market.

Although FDA documents had stated that the agency’s approval of Zolgensma would have been delayed if the company had informed the agency earlier, the company has maintained that the time gap was not related to the approval timeline, but rather the need to conduct a full investigation.

Responding to the Journal, Novartis said that it had been conducting its internal probe in a “very confidential manner” in order to avoid interference by executives from AveXis. Still, FDA officials said in interviews with the Journal that waiting two months seemed “excessive” and that the company should have informed the agency as soon as it suspected the manipulation.

Last week, AveXis said it had appointed a new executive to serve as vice president of research and as chief scientific officer, replacing brothers Brian and Allan Kaspar, whom it said were “no longer with the company.” Citing an unnamed source, STAT reported that they were fired from the company in connection with the data manipulation scandal, though in various published reports attorneys have quoted them as denying wrongdoing.

Photo: FDA, via Flickr (free of all copyright protection)



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