THURSDAY, Nov. 29, 2018 — Firdapse (amifampridine) tablets have been approved by the U.S. Food and Drug Administration for adults with Lambert-Eaton myasthenic syndrome (LEMS).
It’s the first agency-sanctioned treatment for the autoimmune disease that affects the connections between nerves and muscles.
“Patients with LEMS have significant weakness and fatigue that can often cause great difficulties with daily activities,” Dr. Billy Dunn, director of the FDA’S Division of Neurology Products, said in an agency news release. “There has been a long-standing need for a treatment for this rare disorder.”
LEMS affects about three people per 1 million worldwide, the FDA said. The disorder most commonly occurs among people with cancer, such as small cell lung cancer.
The drug’s safety and effectiveness were evaluated in clinical studies involving 64 adults. Those treated with Firdapse were found to have benefited more than those who took a placebo, the agency said.
The drug’s most common side effects included a burning or prickling sensation, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache and elevated liver enzymes.
The agency advised any user who has a hypersensitivity reaction such as rash, hives, itching, fever, swelling or trouble breathing to immediately contact their doctor.
Firdapse is produced by Catalyst Pharmaceuticals, based in Coral Gables, Fla.
The FDA has more about this approval.
Posted: November 2018
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