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Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 31, 2021
Details:
Based on this agreement, Eisai will acquire exclusive development and marketing rights from Kyorin for the agent in the said four countries, and will be responsible for submitting a New Drug Application for the agent.
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Lead Product(s): Mirabegron
Therapeutic Area: Urology Product Name: Myrbetriq
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2021
Details:
The U.S. Food and Drug Administration (FDA) approved Myrbetriq for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq® Granules for the treatment of NDO in pediatric patients aged three years and older.
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Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2021
Details:
Vibegron is a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults.
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Lead Product(s): Mirabegron
Therapeutic Area: Urology Product Name: Myrbetriq
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 January 06, 2021
Details:
The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.
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