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Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Ontozry
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: SK Biopharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2021
Details:
The CHPM opinion is based on a trial (study 017) in which Cenobamate demonstrated significantly higher responder rates (percentage of patients achieving ≥50% reduction in seizures frequency) across all doses during the 12-week maintenance phase compared to placebo.
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Lead Product(s): Clazosentan
Therapeutic Area: Neurology Product Name: ACT-108475
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
Both studies demonstrated that clazosentan reduced the occurrence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH with statistical significance (p<0.01 for both studies).
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Lead Product(s): Fenebrutinib
Therapeutic Area: Neurology Product Name: GDC-0853
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2020
Details:
Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS).
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Lead Product(s): Ofatumumab
Therapeutic Area: Neurology Product Name: OMB157
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
Details:
If approved, ofatumumab will be the first B-cell therapy that can be self-administered at home and has the potential to become a first-choice treatment for use in RMS patients.
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Lead Product(s): Satralizumab
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2020
Details:
Pooled data from two pivotal Phase III open-label extension (OLE) studies show satralizumab was well-tolerated as a monotherapy or in combination with baseline immunosuppressive therapy in people with neuromyelitis optica spectrum disorder (NMOSD).
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Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
Details:
28% of patients receiving cenobamate achieved seizure-freedom (zero seizures) during the study’s maintenance phase, versus 9% receiving placebo1.
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