An old, formerly inexpensive drug called Firdapse was just slapped with a steep new price tag: $375,000.
The Food and Drug Administration approved Firdapse late last month to treat a rare, neuromuscular disorder called Lambert-Eaton myasthenic syndrome. Although it’s the first approved therapy for this disease in the U.S., there’s a catch: For years, hundreds of patients have been receiving an unapproved version of this drug for free.
That’s because Catalyst Pharmaceuticals, the maker of Firdapse, did not actually invent the drug. Rather, a chemical called 3,4-DAP was found in the 1980s to improve symptoms of LEMS. It’s been used, off-label, ever since in the U.S. Catalyst, however, has spent the past several years testing a slightly modified version of 3,4-DAP in clinical trials, and secured approval — and market exclusivity for the next seven years.
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