Novartis said two brothers who were senior researchers at the company were responsible for the manipulation of data behind its $2.1 million gene therapy, Zolgensma, according to The Wall Street Journal.
The FDA found in August that Novartis knew it used inaccurate data when it submitted its application for Zolgensma, which is now the most expensive drug on the market. The scandal emerged because Novartis failed to notify the FDA of the data manipulation until after the drug was approved.
In a letter to the FDA, Novartis said the brothers, Brian and Allan Kaspar, either directly altered or pressured subordinates to alter the data. The letter is dated Aug. 23 but was disclosed to the public Sept. 24.
The letter said the brothers could not offer a credible explanation for any revisions to the data or inconsistencies, according to the WSJ.
It added that Novartis' internal probe into the incident was "significantly drawn out" because the brothers, who were fired in August, would not cooperate and denied the allegations against them.
Read the full report here.
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