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FDA issues approvable letter on prefilled syringe for MS drug Copaxone

Teva also announces study showing that Copaxone reduces incidence of brain lesions

Internet wire

The United States Food and Drug Administration on Tuesday granted an approvable letter to Teva Pharmaceuticals USA for Copaxone (glatiramer acetate injection) to be available in prefilled syringes.

Teva USA is a subsidiary of Israel-based Teva Pharmaceuticals (Nasdaq:TEVA).

Copaxone is positioned to become the first and only relapsing-remitting multiple sclerosis drug therapy to offer its medication in a prefilled syringe approved in the United States, Teva says.

Current injectable MS therapies require mixing and preparation time.

The letter is one of the final steps in the approval process. Teva anticipates that the prefilled glass syringes will become available in early 2002.

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The prefilled syringe is expected to replace the previous mixable form of Copaxone.

"A prefilled syringe should make traveling, working and maintaining an active lifestyle more convenient for people living with MS," said Larry Downey, President and CEO of Teva Neuroscience, another Teva subsidiary.

Copaxone is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis.

Copaxone shown to reduce "black holes" in brain tissue

A study published in the August issue of Neurology showed that Copaxone reduced by 50% the percentage of permanent "black holes" that developed in patients with relapsing-remitting multiple sclerosis, Teva also announced on Tuesday.

Black holes are lesions MS can cause in the brain. If permanent, these lesions are areas where irreversible brain tissue damage has occurred.