When CEO Vas Narasimhan of Novartis heard that there was data falsification going on at Novartis, he immediately took steps to rectify the situation. The Kaspar brothers at Novartis have been held responsible for the data manipulation in gene therapy. At AveXis, the two brothers Briana and Allan Kaspar held top positions as a chief scientific officer and as the vice president. They are the cause of the damaging scandal.
In 2018, AveXis was sold to Novartis and the deal was finalized at $8.7 billion. Zolgensma gene therapy won approval from the Food and Drug Administration on May 24. But Novartis failed to inform regulators about the data manipulation earlier and made the disclosure only on June 28. The Swiss drug giant Novartis had known about the issue earlier, as the two men had been fired even before the information was revealed to regulators. When questioned about it, Novartis had said that internal investigation had been going on. They had waited to get a complete technical analysis and best information before revealing to the FDA. They had then made the disclosure on the data manipulation to the FDA on June 28.
Now, the lawmakers demand details about the investigation. The regulators have criticized the company for not disclosing the facts earlier. The FDA has threatened Novartis, saying that civil or criminal action will be taken against them. Novartis has said that the brothers have not been involved in any AveXis operations and were not with the company after May 2019. Zolgensma helps to treat spinal muscular atrophy, a terrible childhood disease. The breakthrough drug was one of the first in gene therapy and has been approved in the U.S.
The FDA and Novartis have stated that the data manipulation had no bearing on the efficacy or the safety of Zolgensma. The $2.1 million gene therapy which had won approval in May had used inaccurate data in its application.