Reporting data manipulation one month after approval of its gene therapy Zolgensma was not the best decision, confirms CEO.
Novartis’ breakthrough gene therapy Zolgensma (onasemnogene abeparvovec-xioi) for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) was approved by the U.S> Food and Drug Administration (FDA) at the end of May 2019. At the end of June, the company informed the agency that it had discovered the potential manipulation of animal-testing data related to the medication.
It turns out that Novartis learned of the potential data irregularities in March 2019 –– before the FDA made its approval decision, but waited until completing an internal investigation before notifying the agency. U.S. lawmakers, as well as doctors and ethicists, are asserting that Novartis should have informed the FDA as soon as the issue was identified and before the approval decision, rather than waiting until the drug was on the market for several weeks.
In a company call with 12,000 managers, Novartis CEO Vas Narasimhan said the company could have handled the situation better.
