Skip to Main Content

An unusual, decade-long fight over an orphan drug market appears to be at an end after a small, family-run company was defeated in a bruising battle with a rival and has now lost regulatory approval of its medicine.

Late last month, a federal appeals court refused to revisit a ruling that the U.S. Food and Drug Administration improperly approved a drug used to treat a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS, which is sold by Jacobus Pharmaceuticals. As a result, the FDA last week withdrew final approval of the medicine. Shipments to patients are already winding down.

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

GET STARTED

Create a display name to comment

This name will appear with your comment