ST. LOUIS, MO (KPLR) – The FDA rejected the Multiple Sclerosis drug Lemtrada in December. They said the drug-maker didn’t show the drug’s benefits outweigh some serious risks.
There are several forms of Multiple Sclerosis. The most common is relapsing-remitting form, which affects approximately 80-percent of people with MS. They experience clinical attacks followed by periods of remission. The triggers for clinical attacks is unknown after ten years. Relapsing and remitting it usually develops into another form called secondary progressive MS. There are no remissions and the symptoms get worse.
Lemtrada therapy helps at the intermediate relapsing remitting stage of the disease. Patients have periods of normal life before permanent brain and nerve damage sets in. the drug also depletes immune cells that are misdirected and attack the body. There are immediate side affects like nausea and headaches. But, patients relapsed at rates lower than 50-percent. They also experience reductions in brain atrophy and brain lesions.
Lemtrada may only postpone progressive, irreversible paralysis. But, the therapy is also slowing the progression of the disease. Some patients have remained free of clinical disease activity up to 14 years. One potential side effect is called ITP. It causes low platelet counts in the blood and can lead to dangerous bleeding in the clinical trials, one patient died.
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