API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
Details:
Data from the ETNA-AF-Europe Registry provide information on edoxaban in routine clinical practice in subpopulations that include frail patients and those with worsening renal function.
Lead Product(s): Edoxaban Tosylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Lixiana
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2021
Details:
Large routine clinical practice study, ETNA-AF-Europe, demonstrates continued benefits of edoxaban across age groups and supports treatment in elderly patient populations, in line with those observed in ETNA-AF after one year and in ENGAGE AF-TIMI 48.
Lead Product(s): Edoxaban Tosylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Lixiana
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2021
Details:
This application is based on results from the Japanese phase 3 clinical trial (ELDERCARE-AF Study) in 984 non-valvular atrial fibrillation patients of 80 years and above with a high bleeding risk and who are ineligible for other available anticoagulation therapies.
Lead Product(s): Edoxaban Tosylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Du-176b
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2020
Details:
Primary endpoint has been achieved in the Japan phase 3 clinical trial (ELDERCARE AF Study; hereinafter, the study) for the anticoagulant, edoxaban, in elderly patients with non-valvular atrial fibrillation and high bleeding risk.
Lead Product(s): Edoxaban Tosylate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Du-176b
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020