Contribute Try STAT+ Today

In an unexpected move, Canada’s Federal Court quashed the approval of a rare disease drug after the manufacturer of a rival medicine claimed that Health Canada had originally issued an “incorrect and unreasonable” endorsement.

In a 63-page ruling, Justice Martine St-Louis set aside the approval issued by the regulator last year. As a result, the government will now have to review the marketing file submitted by Jacobus Pharmaceuticals, a small, family-run company that sells a drug to treat people with a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS. A competitor, Catalyst Pharmaceuticals (CPRX), is seeking to push back the approval until 2028. We asked Jacobus and Health Canada for comment and will update you accordingly.

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.