FDA Approves Teva's Copaxone to Reduce Frequency in Patients with Relapsing-Remitting Multiple Sclerosis

Copaxone is indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

Copaxone is an injectable medication prescribed to reduce relapse symptoms in patients diagnosed with relapse-remitting multiple sclerosis (RMMS). Copaxone is an immunomodulator that works by preventing the body from damaging its nerve cells (myelin), extending the time between relapse.

Copaxone, manufactured by Teva Marion Partners, is the brand name for a synthetic chemical used to modify the course of multiple sclerosis. The generic name of Copaxone is Glatiramer Acetate which is often shortened to GA. In early trials of the drug, it was known as Copolymer-1 and Cop-1.

While not a cure, Copaxone has been shown in clinical trials to reduce the average relapse rate in people with the relapsing-remitting (RRMS) form of the disease. That doesn't mean that it reduces the relapse rate for all the trial volunteers, just that averaged over the entire volunteer population, the relapse rate was reduced. Copaxone has also been shown to limit the formation of new MS-related lesions in the central nervous system and to reduce brain atrophy.

Copaxone was licensed for the treatment of RRMS in the USA by the Federal Drugs Authority (FDA) in December 1996. It has been approved in Britain, Canada and most of Europe by the national drug regulation organizations.