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# FDA Mostly Denies Novartis Zolgensma Petition
- URL: https://www.fdaweb.com/fda-mostly-denies-novartis-zolgensma-petition/
- Published: 2022-03-17T12:00:00.000Z
- Updated: 2026-09-14T17:36:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151391

FDA has denied the substantive portions of a Novartis Gene Therapies 12/17/21 due diligence petition asking that the agency determine that Regenxbio did not act with due diligence during the regulatory review period of Zolgensma (onasemnogene abeparvovec-xioi) for purposes of patent term extension. The agency [response](https://downloads.regulations.gov/FDA-2020-E-1281-0045/attachment%5F1.pdf?ref=fdaweb.com) says the petition did not set forth sufficient facts and information to merit an investigation.

One of the petition requests was that FDA forward a copy of the petition to the U.S. Patent and Trademark Office (USPTO) “because the petition identifies and corrects misrepresentations by Regenxbio that were previously sent” to the USPTO. The agency granted that request and provided a copy of the petition to the USPTO without comment on the statement about misrepresentations.