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BG9418 (interferon beta-1a)
BG9418 (interferon beta-1a) is a Interferon beta Small molecule drug developed by Biogen. It is currently in Phase 3 development for Multiple sclerosis (relapsing-remitting or relapsing forms). Also known as: Avonex, Avonex®.
BG9418 is interferon beta-1a, which activates interferon signaling pathways to modulate immune responses and reduce inflammation.
BG9418 (interferon beta-1a) is a medication used to treat relapsing-remitting multiple sclerosis. It is also being studied in the context of prenatal exposure and pregnancy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Biogen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BG9418 (interferon beta-1a) |
|---|---|
| Also known as | Avonex, Avonex® |
| Sponsor | Biogen |
| Drug class | Interferon beta |
| Target | Interferon-beta receptor (IFNAR) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Interferon beta-1a binds to interferon-beta receptors on cell surfaces, triggering intracellular signaling cascades that enhance antiviral and immunomodulatory effects. This leads to increased expression of interferon-stimulated genes, reduced pro-inflammatory cytokine production, and restoration of immune tolerance. In multiple sclerosis, these mechanisms help reduce relapse rates and slow disease progression.
Approved indications
- Multiple sclerosis (relapsing-remitting or relapsing forms)
Common side effects
- Flu-like symptoms (fever, chills, myalgia)
- Injection site reactions
- Headache
- Elevated liver enzymes
- Lymphopenia
- Depression or mood changes
Key clinical trials
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
- Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy (PHASE1, PHASE2)
- Tolerability and Quality of Life Study in Participants Who Switched to Avonex Pen
- Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL Study
- A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis (PHASE2)
- Pregnancy Exposure Registry for Avonex (Interferon Beta-1a)
- Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects (PHASE3)
- Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BG9418 (interferon beta-1a) CI brief — competitive landscape report
- BG9418 (interferon beta-1a) updates RSS · CI watch RSS
- Biogen portfolio CI
Frequently asked questions about BG9418 (interferon beta-1a)
What is BG9418 (interferon beta-1a)?
How does BG9418 (interferon beta-1a) work?
What is BG9418 (interferon beta-1a) used for?
Who makes BG9418 (interferon beta-1a)?
Is BG9418 (interferon beta-1a) also known as anything else?
What drug class is BG9418 (interferon beta-1a) in?
What development phase is BG9418 (interferon beta-1a) in?
What are the side effects of BG9418 (interferon beta-1a)?
What does BG9418 (interferon beta-1a) target?
Related
- Drug class: All Interferon beta drugs
- Target: All drugs targeting Interferon-beta receptor (IFNAR)
- Manufacturer: Biogen — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Multiple sclerosis (relapsing-remitting or relapsing forms)
- Also known as: Avonex, Avonex®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing