Novartis Chief Executive Vas Narasimhan, facing an uproar over data manipulation...
FILE PHOTO: CEO Vas Narasimhan of Swiss drugmaker Novartis addresses the company's annual news conference in Basel, Switzerland January 30, 2019. REUTERS/Arnd Wiegmann/File Photo
Novartis has said it knew of discrepancies in Zolgensma data it had submitted to the U.S. Food and Drug Administration before it won approval for the world’s most expensive medicine in May, but delayed informing regulators until June 28 while it completed an internal investigation. Novartis could face possible civil or criminal penalties, the FDA has said. Zolgensma treats spinal muscular atrophy, the leading genetic cause of death in infants.
Novartis said it gave “detailed explanations” on Aug. 23 to the FDA about the company’s investigation into the data manipulation, and addressed regulators’ questions over why the company waited until late June to make disclosures.
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