flexible Food and Drug Administration has once again rescued a biotech company seeking a drug approval based on flawed clinical trial data.

Alexion Pharma (ALXN) won agreement from FDA on Monday to expand the use of its top-selling, ultra-orphan medicine Soliris to treat patients with myasthenia gravis, a rare neuromuscular disease. FDA approved the Soliris label expansion even though the phase 3 clinical trial just missed its primary endpoint.

Unlock this article by subscribing to STAT Plus today. Try it FREE for 30 days and cancel anytime!


What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Morning Rounds newsletter

Your daily dose of what’s new in health and medicine.