API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
Details:
Leading those recommendations is Roche’s Enspryng (satralizumab), which received a positive opinion for the treatment of the rare autoimmune disease neuromyelitis optica spectrum disorders (NMOSD).
Lead Product(s): Satralizumab,Azathioprine,Mycophenolate Mofetil
Therapeutic Area: Neurology Product Name: Enspryng
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Details:
The study showed that avacopan was as effective as prednisone therapy in bringing patients into remission by 26 weeks, and superior to prednisone for sustained remission after 52 weeks.
Lead Product(s): Avacopan,Rituximab,Azathioprine
Therapeutic Area: Immunology Product Name: CCX168
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2020
Details:
If approved, avacopan would be the first orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis.
Lead Product(s): Avacopan,Rituximab,Azathioprine
Therapeutic Area: Immunology Product Name: CCX168
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2020
Details:
The NDA included data from the global, Phase III ADVOCATE trial, which demonstrated statistical superiority in sustaining remission at 52 weeks in the avacopan group compared to the prednisone group.
Lead Product(s): Avacopan,Rituximab,Azathioprine
Therapeutic Area: Immunology Product Name: CCX168
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020