Catalyst Pharma's LEMS drug Firdapse wins FDA nod, as regulators keep the approval engine running at record speed
Turns out, a web error by a company contractor that tipped off investors Catalyst Pharmaceuticals’ $CPRX Firdapse had won approval earlier in the week offered alert traders a quick score. The formal notice that the FDA green-lighted the treatment for the rare neuromuscular disease came through Wednesday evening.
The drug is to be used in patients with Lambert-Eaton Myasthenic Syndrome (LEMS), a rare autoimmune disease that affects about 1 in every 300,000 people. In patients with LEMS, the body’s immune system attacks the neuromuscular junction (the connection between nerves and muscles) and disrupts the ability of nerve cells to send signals to muscle cells, causing weakness and fatigue that typically culminates in difficulties with daily functioning. LEMS is often associated with other autoimmune diseases, and commonly occurs in patients with small cell lung cancer.
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