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Eugene

(61,859 posts)
Wed May 8, 2019, 08:34 PM May 2019

Firdapse: FDA undercuts $375,000 drug in surprise move

Source: CNN

FDA undercuts $375,000 drug in surprise move

By Wayne Drash, CNN
Updated 2115 GMT (0515 HKT) May 8, 2019

(CNN) — The US Food and Drug Administration created a workaround this week that effectively undercuts the $375,000 price tag of a drug that became the poster child for concerns about the pharmaceutical industry.

The FDA announced Monday that it was approving a separate drug for pediatric patients with a rare, painful neuromuscular disease called Lambert-Eaton myasthenic syndrome, also known as LEMS. The disease weakens and fatigues muscles, causing agonizing pain to the point at which patients struggle to walk.

The move sparked celebration in the LEMS community and tanked the stock of Catalyst Pharmaceuticals, maker of the $375,000 drug, called Firdapse. The company's stock price has dropped about 50% since Monday.

The FDA said it was approving Ruzurgi -- made by a small company called Jacobus Pharmaceutical Co. -- for children with LEMS, ages 6 to 17.

-snip-


Read more: https://edition.cnn.com/2019/05/08/health/fda-firdapse-expensive-drug-surprise-move/index.html

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Related: FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder (U.S. Food & Drug Administration)
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