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HyQvia

Phase 2

Multifocal Motor Neuropathy | Small molecule | Neurology |Baxter International Inc.|Last Updated: May 17, 2018

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02556437Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)PHASE2 COMPLETED 18Jun 1, 2016May 1, 2018May 17, 20182 Denmark
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Study Endpoints
Primary Endpoints
Changes in isometric muscle strength
Evaluation at week 0, 12, 24, 36, 48

Measurement of isometric muscle strength of four involved muscle groups

Secondary Endpoints
Changes in disability score
Evaluation at week 0, 12, 24, 36, 48
Changes in clinical evaluation of muscle strength
Evaluation at week 0, 12, 24, 36, 48
Development of Headache and Nausea
During the entire study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia) followed by 24 weeks of treatment with HyQvia
Group BEXPERIMENTAL24 weeks of treatment with HyQvia followed by 24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia)
Interventions
NameTypeDescription
HyQviaDRUGHuman immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection
SubcuviaDRUGHuman immunoglobulin 16% for subcutaneous injection
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age at onset 18 - 65 years. * The presence of asymmetrical limb weakness at onset or motor involvement having a motor nerve distribution in at least two peripheral nerve distributions, predominant upper limb involvement, disabling weakness MRC grade 4 or less in at least one m...

Countries:Denmark
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