Statement made by Vas Narasimhan during Novartis ESG Investor Event in London
September 09, 2019
We understand the FDA’s concerns and appreciate that the circumstances presented by a new gene therapy is something that should be taken into account with regard to timing of FDA notifications of data integrity investigations. Although we are confident that the actions we are taking will prevent data integrity issues from occurring in the future, going forward we are making a voluntary commitment to notify the FDA within five business days of receipt by our quality organization of any credible allegation related to data integrity impacting any pending application in the Novartis Group. We will take a similar approach in other jurisdictions, absent a specific local regulation to the contrary.
Novartis stands behind Zolgensma® (onasemnogene abeparvovec-xioi) for the treatment of children less than 2 years of age with spinal muscular atrophy