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Avonex

Phase 3

Multiple Sclerosis | Small molecule | Immunology |Biogen Inc.|Last Updated: Sep 16, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01181115Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)PHASE3 COMPLETED 60 — — Apr 1, 2010Oct 1, 2011Sep 16, 201310 China
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Study Endpoints
Primary Endpoints
The number and proportion of subjects with adverse events (AEs)
24 weeks
Assessment of clinical laboratory parameters
24 weeks
Assessment of vital signs and physical examinations
24 weeks
Assessment of electrocardiogram (ECG)
24 weeks
Assessment of immunogenicity
24 weeks
Incidence of depression
24 weeks
Incidence of flu-like symptoms
24 weeks
Subject assessment of injection site pain
24 weeks
Clinical assessment of the injection site
24 weeks
Secondary Endpoints
Assess safety of Avonex by evaluating changes in the Expanded Disability Status Scale (EDSS) score over time
24 weeks
Number of Gd-enhancing lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment
at month 3 and month 6
Number of new or newly enlarging T2-weighted lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment
at month 3 and month 6
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active treatmentEXPERIMENTALInterferon treatment for MS
Interventions
NameTypeDescription
AvonexDRUGInterferon treatment for MS
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:China
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