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Label indication AVONEX 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. AVONEX is 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. ( 1 ) FDA label
Also known as BG9418 (Interferon beta-1a), interferon beta-1a, Avonex Pen, Avonex
BG9418 · 3 trials · 2 indications
A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.
| Arm | Type | Description |
|---|---|---|
| Active treatment | EXPERIMENTAL | Interferon treatment for MS |
| Avonex Single-Use Autoinjector | EXPERIMENTAL | Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. |
| Interferon beta-1a | EXPERIMENTAL | Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo IM injection twice weekly for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Avonex | DRUG | Interferon treatment for MS |
| single-use autoinjector with a prefilled liquid Avonex syringe | DEVICE | - |
| Avonex prefilled syringe via manual IM injection | DEVICE | - |
| BG9418 (interferon beta-1a) | DRUG | - |
| Placebo | DRUG | Placebo IM injection, self-administered per protocol. |
Inclusion Criteria: * Ability to understand risks of study and provide informed consent. * Must be Chinese, aged 18 to 55 years inclusive at time of consent. * Must have diagnosis of relapsing MS of 3 months duration at time of screening visit. * Must have at least 1 documented MS attack within 3 y...
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BG9418 is an investigational small molecule developed by Biogen Inc. (ticker BIIB) as a formulation of interferon beta-1a. It has been studied in active ulcerative colitis and multiple sclerosis. The program is in Phase 2 development, and the ulcerative colitis study has been completed.
BG9418 was studied as a treatment for active ulcerative colitis, a form of inflammatory bowel disease. A completed Phase 2 trial, NCT00616434, evaluated interferon beta-1a in adults with active ulcerative colitis across sites in the United States, Canada, Czechia, Hungary, Poland, Russia, and Slovakia.
BG9418 is developed by Biogen Inc., which trades on Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program studying this interferon beta-1a formulation in active ulcerative colitis and multiple sclerosis.
BG9418 is in Phase 2 development. The Phase 2 study in active ulcerative colitis has been completed, and the multiple sclerosis work tied to this program includes a completed Phase 3 trial of the Avonex single-use autoinjector. BG9418 is investigational and has not been approved by the FDA.
Two completed trials are associated with BG9418. NCT00616434 was a Phase 2 study of interferon beta-1a in active ulcerative colitis that enrolled 123 adults. NCT00828204 was a Phase 3 study evaluating the Avonex single-use autoinjector in multiple sclerosis that enrolled 95 participants in the United States.
Yes. BG9418 is also known as BG9418 (interferon beta-1a), so searches for interferon beta-1a in this program refer to the same asset. It is a small molecule formulation of interferon beta-1a developed by Biogen Inc. under the ticker BIIB.