Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 AVONEX, BG9418
Interferon beta-1a · 8 trials · 4 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.
Serum concentrations of human interferon-beta
Serum concentrations of neopterin and beta2-microglobulin
Adverse events throughout the study
Routine physical examination, ECG, safety tests of blood/urine, CXR, oximetry, full pulmonary function tests, spirometry, Dyspnea scale
Cellular MxA protein as an exploratory analysis
| 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. |
| 1st Injection | EXPERIMENTAL | Manual injection with pre-filled syringe. |
| Single-use autoinjector | EXPERIMENTAL | Single-use autoinjector with Avonex pre-filled syringe |
| 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 |
| 1 | EXPERIMENTAL | serum-free avonex given IM |
| Commercial INFB followed by Investigational INFB | OTHER | Process A (currently-approved manufacturing process involving FBS) first, then Process B (new serum-free manufacturing process, without FBS) |
| Investigational INFB followed by Commercial INFB | OTHER | Process B (new serum-free manufacturing process, without FBS) first, then Process A (currently-approved manufacturing process involving FBS) |
| 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 | - |
| Interferon beta-1a | DRUG | 30mcg, IM once-a-week |
| Single-use autoinjector | DEVICE | Single-use autoinjector with Avonex 30mcg pre-filled syringe |
| Placebo | DRUG | Placebo IM injection, self-administered per protocol. |
| Interferon beta 1a | DRUG | - |
| (IM) AVONEX® | DRUG | - |
| Interferon beta-1a (current approved manufacturing process invloving FBS) | DRUG | Single dose of 60 mcg given Intramuscularly (IM) |
| Interferon beta-1a (new process, manufactured without FBS) | DRUG | Single dose of 60 mcg given Intramuscularly (IM) |
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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Interferon beta-1a is a neurology therapy developed by Biogen Inc. (ticker BIIB) for multiple sclerosis and chronic inflammatory demyelinating polyradiculoneuropathy. It has been studied across four clinical trials with a combined enrollment of 416 participants. The program includes completed Phase 1, Phase 2, and Phase 3 studies.
Interferon beta-1a is being studied for multiple sclerosis and chronic inflammatory demyelinating polyradiculoneuropathy, both neurological conditions. The clinical trials conducted to date enrolled patients with multiple sclerosis, including studies of safety, blood levels, immunogenicity, and delivery via a single-use autoinjector.
Biogen Inc., which trades under the ticker BIIB, is the developer of Interferon beta-1a. The company has sponsored the clinical program evaluating the therapy, including trials of serum-free manufacturing and bioequivalence between two different manufacturing processes.
Interferon beta-1a is in Phase 2 development. Its clinical program includes a completed Phase 2 immunogenicity and safety study of serum-free Interferon beta-1a, along with completed Phase 1 and Phase 3 trials. There are currently no active trials listed for this asset.
Interferon beta-1a has been evaluated in four completed trials: NCT01863069, a Phase 1 safety and blood level study; NCT01500408, a Phase 1 bioequivalence study; NCT00915577, a Phase 3 patient satisfaction study of a single-use autoinjector; and NCT00912860, a Phase 2 immunogenicity and safety study of serum-free Interferon beta-1a.
Yes, Interferon beta 1a and interferon beta 1-a are alternative names for Interferon beta-1a. The name is also written as Interferon beta-1a (current approved manufacturing process involving FBS), which refers to the same therapy developed by Biogen Inc. for multiple sclerosis and chronic inflammatory demyelinating polyradiculoneuropathy.