Phase III

Astellas Pharma

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JAPAN Japan

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CPhI North America Online

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FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and sNDA for Myrbetriq Tablets

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.

Urovant Sciences

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Switzerland

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Urovant Sciences Announces Positive Clinical Efficacy and Safety Data from Vibegron EMPOWUR Long Term Extension Study

Lead Product(s): Vibegron

Therapeutic Area: Urology Product Name: KRP114V

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 19, 2020

Details:

Results from the 40-week EMPOWUR extension to the 12-week EMPOWUR trial shows that 75 mg of vibegron was well tolerated over the total exposure of 52 weeks with numerically greater improvements from baseline, compared to tolterodine across QoL and responder efficacy endpoints.