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Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Vimpat
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 October 22, 2020
Details:
The positive opinion is based, in part, on results from a phase 3 study of lacosamide as adjunctive treatment for uncontrolled primary generalized tonic-clonic seizures (PGTCS), recently published in the Journal of Neurology, Neurosurgery & Psychiatry.
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Lead Product(s): Lacosamide
Therapeutic Area: Neurology Product Name: Vimpat
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 August 31, 2020
Details:
Study met primary and secondary endpoints of significantly lowering the risk of developing a second primary generalized tonic-clonic seizure during a 24-week treatment and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo.
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Lead Product(s): Padsevonil
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 March 13, 2020
Details:
ARISE did not reach statistical significance for either of the two primary endpoints.
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