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.
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