Mar 05, 2009
FDA Extends Copaxone Labeling To Include Those Experiencing First Attack and Having MRI Scan Suggestive Of MS
According to the drug’s sponsor, the U.S. Food and Drug Administration (FDA) has extended the labeling of Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries) to include people with MS who have experienced a first clinical episode and have MRI features consistent with MS. The FDA based its decision on the findings of the “PreCISe” study, funded by Teva.
Background: The diagnosis of clinically definite MS requires two neurological events suggesting demyelination (loss of nerve-fiber insulation) in the brain and spinal cord separated in time and in location. Studies have shown that individuals who experience a clinically isolated syndrome (a single occurrence of a sign or symptom of demyelination) and multiple clinically “silent” MRI-detected brain lesions are at high risk for developing clinically definite MS within several years. Individuals who have similar neurologic problems but no evidence of MRI-detected lesions are at relatively low risk for developing MS over the same time period.
The PreCISe Study: Dr. Giancarlo Comi presented results of this study at the Annual Meeting of the American Academy of Neurology in 2008. A total of 481 people with CIS with lesions typical of MS on brain MRIs were randomly assigned to receive either Copaxone (given by daily under-the-skin injections) or inactive placebo for up to 36 months. The primary outcome measure was the time it took individuals to experience a second attack that would confirm the diagnosis of definite MS. In the Copaxone group, the risk of developing clinically definite MS was reduced by 45% versus placebo, and the time to development of definite MS was delayed by 386 days more than in the placebo group. The proportion of patients who developed MS was 43% in the placebo group versus 25% in the Copaxone group. (Abstract #LBS.003)
In addition to Copaxone, both Avonex® (interferon beta-1a, Biogen Idec) and Betaseron® (interferon beta-1b, Bayer Healthcare Pharmaceuticals) are approved to treat relapsing MS as well as a first clinical episode with MRI findings consistent with MS.
Based on these results, Teva stopped the study early and gave all participants, including those who were taking inactive placebo, an opportunity to receive Copaxone for two years. Data were then presented to the FDA in an effort to expand labeling of Copaxone to include earliest demyelinating event in individuals at high risk for developing clinically definite MS.
Further data from the PreCISe study was presented at the World Congress of MS in 2008, and indicated that Copaxone may improve neural health. Studying a subgroup of 34 people, Douglas L. Arnold, MD (NeuroRx, Montreal) and colleagues used magnetic resonance spectroscopy to examine levels of NAA – a marker of nerve fiber integrity. These levels were significantly higher in people taking Copaxone compared to those on placebo at one year. (Abstract #17)
Comment: Research suggests that damage to brain and spinal cord tissues can occur early in the disease course of multiple sclerosis, and that early use of disease-modifying therapies can delay onset and forestall to some extent future disability. The FDA’s approval of expanded labeling for the use of Copaxone in people who have had a single attack and MRI scan suggestive of MS adds another option for early treatment, and sends a signal to physicians and third-party insurers that this is an appropriate treatment for individuals with this condition.
Individuals interested in the use of Copaxone for earliest demyelinating event suggestive of MS should contact their personal physicians. Additional information about Copaxone can be obtained through the Copaxone support program, Shared SolutionsTM,
1-800-887-8100, or www.copaxone.com.
Read more about “pre-diagnosed” MS.
Copaxone is a registered trademark of Teva Pharmaceutical Industries.
Avonex is a registered trademark of Biogen Idec.
Betaseron is a registered trademark of Bayer Healthcare Pharmaceuticals.