Interferon beta-1A
Highest phase reached
Approved
Drug type
Protein
First approval year
1996
- First approval year
- 1996
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Interferon beta-1A
- avonex
- Avonex
- cinnovex
- Cinnovex
- interferon beta 1a avonex
- interferon beta 1a rebif
- Interferon beta-1a (avonex)
- Interferon beta-1a (rebif)
- neoferon
- Neoferon
- rebif
- Rebif
- bcd 033 interferon beta 1a
- BCD-033 (interferon beta 1a)
- BG9418 (interferon beta 1-a)
- BG9418 (interferon beta-1a)
- BG9418 (Interferon beta-1a)
- INTERFERON .BETA.-1A
- Interferon beta - 1a (IFN)
- interferon beta 1 a
- interferon beta 1-a
- Interferon beta 1-a
- INTERFERON BETA 1-A
- interferon beta 1a
- Interferon beta 1a
- INTERFERON BETA 1A
- interferon beta 1a ema epar
- interferon beta 1a jan
- interferon beta 1a mi
- interferon beta 1a purple book cder
- interferon beta 1a recombinant
- interferon beta 1a recombinant human
- interferon beta 1a recombinant vandf
- interferon beta 1a usan
- interferon beta 1a usp rs
- interferon beta 1a vandf
- interferon beta 1a who dd
And 30 more, listed on the interactive page.
- ATC classification codes
- L03AB07
Sources for recorded values
- CAS registry numbers
- 145258-61-3
- ChEMBL ID
- CHEMBL1201562
- RxNorm IDs (RxCUI)
- 75917
- FDA ingredient codes (UNII)
- XRO4566Q4R
- Applicant
- BIOGEN
- Approval date
- 17 May 1996
- Application number
- BLA103628
- Status
- Authorised
- Status date
- 13 Mar 1997
- Authorisation date
- 13 Mar 1997
- Approved indications
- Avonex is indicated for the treatment of: patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three years without evidence of continuous progression between relapses; Avonex slows the progression of disability and decreases the frequency of relapses; patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite MS. Avonex should be discontinued in patients who develop progressive MS.
- Product number
- EMEA/H/C/000102
- Authorisation holder
- Biogen Netherlands B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Multiple Sclerosis
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 17 May 2003
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
Administration routes
- Parenteral
- Mechanism
- Interferon alpha/beta receptor agonist
- Action type
- Agonist
- Target
- Interferon alpha/beta receptor
- Protein identifier
- P17181
- Mechanism
- Interferon alpha/beta receptor agonist
- Action type
- Agonist
- Target
- Interferon alpha/beta receptor
- Protein identifier
- P48551
Open Targets mechanisms
- Mechanism
- Interferon alpha/beta receptor agonist
- Action type
- Agonist
- Target
- Interferon alpha/beta receptor
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Crohn Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Stroke
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Hepatitis C
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003047
- Subject identifier
- D006526
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Multiple Sclerosis, Relapsing-Remitting
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003929
- Subject identifier
- D020529
- Condition
- Influenza, Human
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007328
- Subject identifier
- D007251
- Condition
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000868
- Subject identifier
- D020277
- Condition
- Multiple Organ Failure
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001373
- Subject identifier
- D009102
- Condition
- Alzheimer Disease
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004975
- Subject identifier
- D000544
- Condition
- Asthma
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004979
- Subject identifier
- D001249
- Condition
- Multiple Sclerosis
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005301
- Subject identifier
- D009103
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition
- Respiratory Distress Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100130
- Subject identifier
- D012128
- Condition identifier
- EFO_0000341
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000384
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000712
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000729
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003047
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003929
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007541
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000868
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001373
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004975
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004979
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005002
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005011
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005101
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005231
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005301
- Condition identifier
- MONDO_0005301
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005314
- Condition identifier
- MONDO_0006502
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0006702
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008039
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0100096
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0100130
- Highest recorded phase
- 3
And 1 more, listed on the interactive page.
- Event
- balance disorder
- Reports
- 686
- Reporting signal score
- 539.802
- Event
- breast cancer
- Reports
- 660
- Reporting signal score
- 784.863
- Event
- central nervous system lesion
- Reports
- 426
- Reporting signal score
- 772.182
- Event
- depression
- Reports
- 1,334
- Reporting signal score
- 686.302
- Event
- fall
- Reports
- 2,436
- Reporting signal score
- 1,368.29
- Event
- gait disturbance
- Reports
- 1,365
- Reporting signal score
- 1,014.01
- Event
- general symptom
- Reports
- 249
- Reporting signal score
- 551.006
- Event
- hypoaesthesia
- Reports
- 957
- Reporting signal score
- 521.387
- Event
- influenza like illness
- Reports
- 2,628
- Reporting signal score
- 4,902.43
- Event
- injection site erythema
- Reports
- 1,073
- Reporting signal score
- 590.346
- Event
- memory impairment
- Reports
- 890
- Reporting signal score
- 709.961
- Event
- multiple sclerosis
- Reports
- 1,785
- Reporting signal score
- 4,289.16
- Event
- multiple sclerosis relapse
- Reports
- 3,592
- Reporting signal score
- 9,069.19
- Event
- optic neuritis
- Reports
- 361
- Reporting signal score
- 643.937
- NCT00037102
- NCT00110396
- NCT00146068
- NCT00151801
- NCT00217295
- NCT00246324
- NCT00273364
- NCT00404352
- NCT00472797
- NCT00492765
- NCT00493077
- NCT00501943
- NCT00618527
- NCT00619307
- NCT00784836
- NCT00813709
- NCT00828204
- NCT00906399
- NCT00912860
- NCT00913250
- NCT00913666
- NCT00915460
- NCT00915577
- NCT01085318
- NCT01181115
And 58 more, listed on the interactive page.
- Dose
- 30 micrograms
- Route
- Intramuscular
- How often
- Once a week
- Discard remaining product after each titrated dose
- Do not inject into irritated or infected skin
- Initial dose of 7.5 micrograms, can be titrated up by 7.5 micrograms each week for 3 weeks until 30 micrograms is reached
- Perform first injection under supervision of a healthcare professional
- Rotate injection sites
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- MSYNLLGFLQRSSNFQCQKLLWQLNGRLEYCLKDRMNFDIPEEIKQLQQFQKEDAALTIYEMLQNIFAIFRQDSSSTGWNETIVENLLANVYHQINHLKTVLEEKLEKEDFTRGKLMSSLHLKRYYGRILHYLKAKEYSHCAWTIVRVEILRNFYFINRLTGYLRN
- 59627-002
- 59627-003
- 59627-222
- 59627-333
- 44087-0022
- 44087-0044
- 44087-0188
- 44087-3322
- 44087-3344
- 44087-8822
Related records
Trials (343)
- (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI
- A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A
- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid Tumors
- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2062 in Patients With Solid Tumors
- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of VG2025 Intravenous Injection in Subjects With Advanced Solid Tumors
- A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT)
- A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age
- A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
- A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes
- A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers
- A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers
- A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis
- A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years
- A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
- A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
- A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody
- A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
- A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
- A Phase III Trial of Recombinant Human Apo-2 Ligand for Injection
- A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
Approved for (2)
- Multiple sclerosis
- Neoplasm
In development for (15)
- Adult acute respiratory distress syndrome Phase 3
- Alzheimer disease Phase 2
- Asthma Phase 2
- Chronic inflammatory demyelinating polyradiculoneuropathy Phase 2
- Chronic obstructive pulmonary disease Phase 2
- COVID-19 Phase 3
- Crohn disease Phase 2
- Hepatitis C virus infection Phase 3
- Influenza Phase 3
- Multiple organ dysfunction syndrome Phase 2
- Pneumonia Phase 3
- Relapsing-remitting multiple sclerosis Phase 3
- Stroke disorder Phase 1
- Ulcerative colitis Phase 2
- Viral pneumonia Phase 2