Novartis falls as FDA says it knew about errors in application

Tuesday, 06. August 2019 20:02

Shares of pharmaceutical company Novartis International AG tumbled on Tuesday after the United States Food and Drug Administration revealed that the drugmaker knew its application for its gene therapy contained errors.

"On June 28, following the FDA’s approval of the product, the agency was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application and reviewed by the FDA," Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said.

Zolgensma, a one-time treatment for spinal muscular atrophy, was approved by the FDA back in May and is the world's most expensive drug.

Shares of the drugmaker sank 3.87% to $87.21 per share at 1:55 pm ET.

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Breaking the News / JC