Skip to Main Content
Contribute Try STAT+ Today

AveXis, the gene therapy subsidiary of Swiss pharma giant Novartis, was aware of “data manipulation” involving its Zolgensma gene therapy for spinal muscular atrophy before it was approved in May, but did not inform the Food and Drug Administration until later, the agency said Tuesday.

Zolgensma should remain on the market, Peter Marks, the director of the agency’s Center for Biologics Evaluation and Research, said in a statement. But the FDA continues to review the data issue to see if further action is required, which may lead to “civil or criminal penalties,” according to the statement.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


What is it?

STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
  • In other businesses, data manipulation gets people fired, and opens the can of worms for very stiff fines / lawsuits / jail-terms / de-licensing, etc. This should thus also apply to AveXis (or its new owner Novartis). And yet even more urgently so as this business effects human lives.

Comments are closed.