Tecfidera
Drug - Tecfidera [dimethyl fumarate]
October 2013
Therapeutic Area - Multiple Sclerosis
Approval criteria
- Tecfidera is being used as monotherapy for relapsing forms of multiple sclerosis AND
- After documented compliance of at least 6 months of therapy, unless contraindicated, has had an inadequate response to Copaxone
Inadequate response is defined as meeting two of the following three criteria during treatment with another disease modifying drug:
- Unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment
- The patient continues to have CNS lesion progression as measured by MRI
- The patient continues to have worsening disability. Examples of worsening disability include, but are not limited to, decreased mobility or decreased ability to perform activities of daily living due to disease progression.
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