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Details:
Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a, blocking neutrophil activation and migration. Currently being developed for the treatment of ANCA-associated vasculitis.
Lead Product(s): Avacopan,Rituximab
Therapeutic Area: Rare Diseases and Disorders Product Name: Tavneos
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2023
Details:
Tavneos (avacopan) is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the anaphylatoxin C5a, blocking neutrophil activation and migration. Currently being developed for the treatment of ANCA-associated vasculitis.
Lead Product(s): Avacopan,Rituximab
Therapeutic Area: Immunology Product Name: Tavneos
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 07, 2023
Details:
The acquisition includes TAVNEOS (avacopan), an orally administered selective complement 5a receptor inhibitor that was approved by the U.S. FDA in October 2021 as an adjunctive therapy for adults with severe active ANCA-associated vasculitis.
Lead Product(s): Avacopan,Rituximab
Therapeutic Area: Immunology Product Name: Tavneos
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 20, 2022
Details:
TAVNEOS® (avacopan) is indicated as adjunctive treatment of adult patients with severe active ANCA-associated vasculitis (granulomatosis with polyangiitis) and microscopic polyangiitis [MPA] in combination with standard therapy including glucocorticoids.
Lead Product(s): Avacopan,Rituximab
Therapeutic Area: Immunology Product Name: Tavneos
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 24, 2022
Details:
Tavneos® (avacopan) is an orally administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1,reduces the ability of those cells to do damage in response to C5a activation.
Lead Product(s): Avacopan,Rituximab,Cyclophosphamide
Therapeutic Area: Immunology Product Name: Tavneos
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2022
Details:
The acquisition of ChemoCentryx represents a compelling opportunity for Amgen to add long leadership in inflammation and nephrology with TAVNEOS (avacopan), a first-in-class medicine for patients with serious autoimmune disease, preferably ANCA-associated vasculitis.
Lead Product(s): Avacopan
Therapeutic Area: Immunology Product Name: Tavneos
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: $3,700.0 million Upfront Cash: $3,700.0 million
Deal Type: Acquisition August 04, 2022
Details:
TAVNEOS® (avacopan), an orally administered selective complement 5a receptor inhibitor, and have potential application in C3 glomerulopathy, as well as the immuno-oncology potential of CCX559, an orally administered small molecule PD-L1 inhibitor.
Lead Product(s): Avacopan,Rituximab
Therapeutic Area: Immunology Product Name: Tavneos
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
The findings support the Company’s plans to advance TAVNEOS® (avacopan) into Phase III development for the treatment of patients with Hurley Stage III (severe) hidradenitis suppurativa.
Lead Product(s): Avacopan
Therapeutic Area: Dermatology Product Name: Tavneos
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2022
Details:
Tavneos (avacopan), approved by FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases.
Lead Product(s): Avacopan,Rituximab
Therapeutic Area: Immunology Product Name: Tavneos
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2022
Details:
EU approval for Tavneos (avacopan) is based on culminating in the results from the pivotal phase-III trial ADVOCATE in 331 patients with ANCA-associated vasculitis also met its primary endpoints of disease remission at week 26 and sustained remission at week 52.
Lead Product(s): Avacopan,Rituximab
Therapeutic Area: Immunology Product Name: Tavneos
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2022
Details:
The positive opinion recommending marketing authorization for TAVNEOS (avacopan) in combination with a rituximab or cyclophosphamide regimen, indicated for the treatment of severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
Lead Product(s): Avacopan,Rituximab
Therapeutic Area: Immunology Product Name: Tavneos
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 12, 2021
Details:
TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis in combination with standard therapy including glucocorticoids.
Lead Product(s): Avacopan,Rituximab
Therapeutic Area: Immunology Product Name: Tavneos
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 October 08, 2021
Details:
The Committee voted on three questions presented by the FDA on whether the efficacy data support approval of avacopan for the treatment of adult patients with AAV, safety profile of avacopan and benefit-risk profile of the product.
Lead Product(s): Avacopan,Interleukin 2
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 May 06, 2021
Details:
If approved, avacopan would be the first-in-class orally administered selective complement 5a receptor inhibitor exerting an anti-inflammatory effect, for the treatment of patients with ANCA-associated vasculitis.
Lead Product(s): Avacopan,Rituximab,Cyclophosphamide
Therapeutic Area: Immunology Product Name: CCX168
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kissei Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2021
Details:
ChemoCentryx plans to discuss the results with the U.S. Food and Drug Administration as it has obtained evidence of avacopan’s ability to improve renal function, being well-tolerated in C3G patients to date.
Lead Product(s): Avacopan
Therapeutic Area: Immunology Product Name: CCX168
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2020
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:
Avacopan demonstrates statistically significant dose-dependent improvement in HiSCR vs. placebo in pre-specified Hurley Stage III (severe HS) patients at 12 weeks; numerical improvement observed with avacopan treatment in overall study population.
Lead Product(s): Avacopan
Therapeutic Area: Dermatology Product Name: CCX168
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 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
Details:
The Company’s NDA submission is supported by the results of its pivotal 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,Cyclophosphamide
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 July 09, 2020
Details:
Pivotal trial demonstrated avacopan’s statistical superiority in sustaining remission at 52 weeks over the glucocorticoid-containing standard-of-care therapy.
Lead Product(s): Avacopan,Rituximab,Cyclophosphamide
Therapeutic Area: Immunology Product Name: Undisclosed
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 June 03, 2020
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