US Authorities Launch Investigation Into Novartis Gene Therapy Zolgensma

(MENAFN- Swissinfo) The United States Food and Drug Administration (FDA) has launched an investigation to determine if Swiss pharma giant Novartis' gene therapy Zolgensma (onasemnogene abeparvovec) poses a“serious risk” of malignant tumours developing in patients. Select your language

Generated with artificial intelligence. Listening: US authorities launch investigation into Novartis gene therapy Zolgensma This content was published on November 9, 2026 - 10:26 2 minutes Keystone-SDA

Français fr Novartis: la FDA enquête sur un effet cancérigène du Zolgensma Original Read more: Novartis: la FDA enquête sur un effet cancérigène du Zolg

The investigation follows reports issued last week by Novartis regarding tumours detected in patients who had previously used the therapy. Three of the cases involved tumours associated with an oncogene capable of causing cancer if overexpressed.

“In two of these cases, molecular analysis of the tissue demonstrated integration of the Zolgensma adeno-associated viral vector into the host genome,” the FDA stated in a press release.

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This content was published on Apr 23, 2024 Swiss pharma giant Novartis launched Zolgensma five years ago with a price tag of $2.1 million. What happened to it?

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