FDA Approves New Dose of Copaxone To Be Taken Less Frequently

NEW YORK, Jan. 30 -- The National Multiple Sclerosis Society issued the following news:

On January 28, the U.S. Food and Drug Administration approved a new dose of glatiramer acetate (Copaxone,(TM) Teva Pharmaceuticals Industries, Ltd.) injected under the skin three times per week, at double the standard 20mg/mL dose, for relapsing MS. This long-approved MS disease-modifying therapy is normally taken every day. The approval was based on benefits and safety demonstrated by a company-sponsored, one-year, phase III trial comparing the higher, less-frequent dose of Copaxone with placebo. Additional information regarding availability of the new dose will be forthcoming.

The clinical trial results suggested that at the 40mg/mL dosing regimen taken three times a week, the therapy reduced relapses by 34% compared with placebo, and significantly reduced the occurrence of MRI-detected MS lesions - impacts generally in line with the every-day 20mg dosing schedule. The 40mg dose was well tolerated, but produced injection-site reactions often seen with the standard dose. Clinical trial results were published in June 2013 in the Annals of Neurology (Ann Neurol. 2013 Jun;73(6):705-13). http://www.ncbi.nlm.nih.gov/pubmed/23686821

The trial did not compare the new dose with the standard dose, so there is no direct information about any differences in effectiveness between the new and previous dose. There is also no information about whether or how to switch to the new dose. That is a question that is best discussed between people with MS and their healthcare providers. According to a company press release, the 20mg/mL dose of Copaxone for daily injection will remain available.

For information about 40mg, three times per week Copaxone, individuals may contact their doctors or Teva's Shared Solutions(TM) helpline: 1-800-887-8100.

Download prescribing and patient information sheet (.pdf) https://www.copaxone.com/Resources/pdfs/PrescribingInformation.pdf

Read more about therapies for MS. http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-a...

Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
Shared Solutions is a registered service mark of Teva Neuroscience, Inc.

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