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FDA takes no action against Novartis after gene therapy data inquiry

The U.S. Food and Drug Administration (FDA) said it will not sanction Novartis over alleged data manipulation involving the Swiss drugmaker’s gene therapy Zolgensma.

Novartis, which updated policies meant to speed data integrity disclosures after the FDA’s inquiry, said it was glad to have the matter resolved.

“We are pleased with this positive outcome and reiterate our firm commitment to data integrity and transparency in our engagements with regulators,” the company said in a statement.

The FDA said in August that some data from early testing of a $2.1 million-per-patient gene therapy for the muscle-wasting genetic disease spinal muscular atrophy (SMA) was manipulated.

However, the U.S. agency left the treatment on the market, judging it to be safe and effective. Zolgensma, in addition to approval in the United States and Japan, is now awaiting the blessing of European regulators.

“FDA has completed its review of the information and records of the inspection, the evidence collected, and the firm’s responses as well as the corrective actions,” it said in a statement provided to media outlets including Biopharma Dive.

“Objectionable conditions were found and documented but the objectionable conditions observed during the inspection do not meet the threshold for regulatory action,” the FDA added.

Basel-based Novartis blamed scientists at its Avexis unit, who have since left, for the data issues.

Meeta Ramnani
Meeta Ramnani
Meeta develops credible content about various markets based on deep research, opinions from experts and inputs from industry leaders. As the managing editor at Smart Industry News, she assures that every piece of news and article adds to the knowledge of decision makers. An avid bike rider, Meeta, is a postgraduate from Indian Institute of Journalism and New Media (IIJNM) Bangalore, where her specialization was Business Journalism. She carries experience from mainstream print media including The Times Group and Sakal Media Group.