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Label indication BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive… FDA label
Betaseron · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | - |
| Arm 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Betaseron (Interferon beta-1b, BAY86-5046) | DRUG | 250 mcg |
Inclusion Criteria: Diagnosis of RRMS as defined by any of the following McDonald diagnostic criteria (McDonald et al 2001; see Appendix 16.1.1 \[(Protocol Appendix 5\]): * Two relapses and objective clinical evidence (history or present) of at least 2 lesions * Two relapses and objective clinical...
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Betaseron is used for multiple sclerosis, specifically relapsing-remitting multiple sclerosis. It is a small molecule therapy in the neurology therapeutic area. The BEYOND Pilot Study enrolled adults with relapsing-remitting multiple sclerosis in the United States.
Betaseron is developed by Bayer AG, which trades under the ticker BAYRY. Bayer AG is the company behind the drug also known by the identifiers interferon beta-1b and BAY86-5046.
Betaseron is in Phase 2 development based on the BEYOND Pilot Study, which was a Phase 2 trial. That study is completed, and no active trials are currently listed. The drug is investigational in this development context and is not described as FDA approved.
Betaseron has been studied in the BEYOND Pilot Study, registered as NCT00893217. That Phase 2 trial was completed, enrolled 71 participants, and was randomized, double blind, and active controlled. It enrolled patients aged 18 years and older of all sexes in the United States.
Yes, Betaseron is also known as interferon beta-1b and by the code BAY86-5046. These names refer to the same drug developed by Bayer AG for multiple sclerosis, so searches for interferon beta-1b or BAY86-5046 lead to the same asset.