C5L2

ChemoCentryx Announces Presentation at the Society for Investigative Dermatology Meeting Highlighting the Role of Tunnels in Driving Ongoing Disease in Hidradenitis Suppurativa

Retrieved on: 
Wednesday, May 18, 2022
Food, U.S. Securities and Exchange Commission, SID, Full, Cell, Terminology, Private Securities Litigation Reform Act, SEC, Receptor (biochemistry), Cancer, Risk, Annual report, Annual general meeting, Medication, European Commission, Anti-neutrophil cytoplasmic antibody, Degenerative disease, News, Phase, Clinical trial, Granulomatosis with polyangiitis, Microscopic polyangiitis, SAN, Neutrophil, C5L2, Chemokine, Achievement, GLOBE, Inflammation, Lupus nephritis, Company, US Foods, Hidradenitis suppurativa, Goal, Abscess, Adult, C5a, FDA, HS, Vasculitis, Society, AURORA, Security (finance), Nasdaq, Patient, Poster, Granuloma, Gene, Safety, Medical device, Vaccine, Pharmaceutical industry, ANCA

SAN CARLOS, Calif., May 18, 2022 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that a poster will be presented at the Society for Investigative Dermatology (SID) 2022 Annual Meeting, to be held May 18-21, 2022 in Portland, Oregon, that highlights unique immunological profiles of the subdermal tunnels in hidradenitis suppurativa, and how these profiles are differentiated with the stage of disease severity. 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.

Key Points: 
  • Hidradenitis suppurativa (HS) is a chronic, disabling, inflammatory skin disease characterized by neutrophil-rich inflammatory nodules, abscesses, and tunnels (sinus tracts).
  • The complement 5a (C5a) receptor (C5aR) is highly expressed on neutrophils and is a major driver of the pro-inflammatory functions.
  • Clinical assessment of the severity of HS includes staging using the Hurley system, where Hurley Stage III disease defines severe HS and Hurley Stage II denotes a more moderate disease presentation.
  • ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), severe hidradenitis suppurativa (HS) and Lupus Nephritis (LN).

ChemoCentryx Announces EU Approval of TAVNEOS® (avacopan) for the Treatment of ANCA-Associated Vasculitis

Retrieved on: 
Wednesday, January 19, 2022
Granuloma, University of Cambridge, GPA, Rituximab, Patient, News, SAN, Hidradenitis suppurativa, Â, Private Securities Litigation Reform Act, Union, SEC, Microscopic polyangiitis, Regulation of tobacco by the U.S. Food and Drug Administration, MPA, Safety, Adult, Achievement, Vifor Pharma, Risk, GLOBE, C5L2, U.S. Securities and Exchange Commission, C5a, Nasdaq, Lupus nephritis, Goal, Company, Granulomatosis with polyangiitis, Kidney, Anti-neutrophil cytoplasmic antibody, HS, Cancer, Food, Inflammation, Vasculitis, Glucocorticoid, Annual report, European Commission, Receptor (biochemistry), FDA, Cell, Full, Security (finance), Medication, Degenerative disease, University, Terminology, Pharmaceutical industry, ANCA

SAN CARLOS, Calif., Jan. 19, 2022 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that TAVNEOS® (avacopan) has been approved within the European Union in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis. This approval follows the U.S. Food and Drug Administration (FDA) approval of TAVNEOS in October 2021. TAVNEOS will receive marketing authorization in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

Key Points: 
  • This approval follows the U.S. Food and Drug Administration (FDA) approval of TAVNEOS in October 2021.
  • TAVNEOS will receive marketing authorization in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and Lupus Nephritis (LN).
  • In the United States, ChemoCentryx markets TAVNEOS (avacopan), the first approved orally-administered inhibitor of the complement 5a receptor as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis.

VFMCRP receives EU approval for Tavneos® for the treatment of ANCA-associated vasculitis

Retrieved on: 
Wednesday, January 19, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, End organ damage, University of Cambridge, GPA, Medicine, Rituximab, Patient, Kidney, Inflammation, Union, Microscopic polyangiitis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MPA, Neutrophil, European, Adult, ISIN, Vifor Pharma, Death, Fresenius Medical Care, Health, Standard of care, Receptor (biochemistry), C5L2, C5a, Time, View, European Commission, SIX Swiss Exchange, ANCA, Granulomatosis with polyangiitis, Quality of life, Hidradenitis suppurativa, Anti-neutrophil cytoplasmic antibody, HS, Atypical hemolytic uremic syndrome, Royal commission, Food, Failure, Glucocorticoid, Infection, FDA, Nephrology, Cell, Steroid, Conditional sentence, University, Pharmaceutical industry, EU, Vifor Pharma Group, ANCA-associated vasculitis, Tavneos® (avacopan), VIFOR PHARMA GROUP, ANCA-ASSOCIATED VASCULITIS, TAVNEOS® (AVACOPAN)

The approval is consistent with expectations and overall follows the U.S. Food and Drug Administration (FDA) approval of Tavneos in October 2021 for the same indication.

Key Points: 
  • The approval is consistent with expectations and overall follows the U.S. Food and Drug Administration (FDA) approval of Tavneos in October 2021 for the same indication.
  • The European Commissions approval of Tavneos is a milestone for the treatment of ANCA-associated vasculitis in Europe and for patients living with this debilitating disease, said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma.
  • They will now have available a new class of medication that meets major unmet medical needs in the treatment of ANCA-associated vasculitis.
  • Tavneos was developed by ChemoCentryx Ltd. who is also developing Tavneos for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS).

Positive Recommendation for Use of TAVNEOS™ (avacopan) in ANCA Vasculitis Adopted by European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP)

Retrieved on: 
Friday, November 12, 2021
Safety, Glucocorticoid, Achievement, Cancer, Private Securities Litigation Reform Act, News, Lupus nephritis, SAN, European Commission, Security (finance), European Union, Terminology, Vasculitis, EMA, Food, Union, Medicine, MPA, Granulomatosis with polyangiitis, Goal, Hidradenitis suppurativa, C5L2, Annual report, HS, Risk, Rituximab, Microscopic polyangiitis, Receptor (biochemistry), GPA, Regulation of tobacco by the U.S. Food and Drug Administration, Company, U.S. Securities and Exchange Commission, Anti-neutrophil cytoplasmic antibody, GLOBE, C5a, Degenerative disease, SEC, Inflammation, Granuloma, Nasdaq, Patient, Cell, European Medicines Agency, Vifor Pharma, FDA, Selected Patient Information Resources in Asian Languages, CHMP, Adult, Vaccine, Pharmaceutical industry

Following the CHMPs positive opinion, theEuropean Commissionwill render an official decision as to the authorization of the use of TAVNEOS in the European Union in January 2022.

Key Points: 
  • Following the CHMPs positive opinion, theEuropean Commissionwill render an official decision as to the authorization of the use of TAVNEOS in the European Union in January 2022.
  • ViforPharmahas granted Kissei Pharmaceutical Co., Ltd. an exclusive license to commercialize TAVNEOS (avacopan), in Japan, where TAVNEOS was approved for use in ANCA vasculitis patients in September.
  • Vifor Pharma will pay ChemoCentryx royalties in the teens to the mid-twenties percent on potential ex-US net sales off one aggregate net sales line.
  • Please click here for Patient Information for TAVNEOS in the United States, including Important Safety Information and Full Prescribing Information.

VFMCRP receives positive CHMP opinion for Tavneos® for the treatment of ANCA-associated vasculitis

Retrieved on: 
Friday, November 12, 2021
Biotechnology, Pharmaceutical, Health, Fresenius Medical Care, SIX Swiss Exchange, Food, Neutrophil, Granulomatosis with polyangiitis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Rituximab, C5a, European Commission, Cell, European, Kidney, Infection, Failure, End organ damage, Cyclophosphamide, MPA, Standard of care, C5L2, HS, ISIN, Conditional sentence, Time, Nephrology, Patient, CHMP, Adult, ART, View, Receptor (biochemistry), Vasculitis, Inflammation, Union, Steroid, LR, Granuloma, Atypical hemolytic uremic syndrome, European Union, ANCA, EMA, Hidradenitis suppurativa, GPA, Death, Microscopic polyangiitis, Royal commission, European Medicines Agency, Vifor Pharma, Vaccine, Pharmaceutical industry, Vifor Pharma Group, ANCA-associated vasculitis, Tavneos® (avacopan), VIFOR PHARMA GROUP, ANCA-ASSOCIATED VASCULITIS, TAVNEOS® (AVACOPAN)

A positive opinion by the CHMP is a formal scientific recommendation supporting marketing authorization across the EU.

Key Points: 
  • A positive opinion by the CHMP is a formal scientific recommendation supporting marketing authorization across the EU.
  • CHMP Opinions are the basis for the European Commissions final Decision regarding marketing authorization for Tavneos, which is expected in Q1 2022.
  • Tavneos was developed by ChemoCentryx Ltd. who is also developing Tavneos for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS).
  • The U.S. Food and Drug Administration has granted Tavneos orphan-drug designation for ANCA-associated vasculitis, C3G and atypical hemolytic uremic syndrome.

VFMCRP announces approval for TAVNEOS® (avacopan) for the treatment of ANCA-associated vasculitis in Japan

Retrieved on: 
Monday, September 27, 2021
Biotechnology, General Health, Pharmaceutical, Health, ISIN, Hyperphosphatemia, Cyclophosphamide, Vasculitis, Standard of care, SIX Swiss Exchange, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Population, Death, Nephrology Dialysis Transplantation, Rituximab, Urology, Cell, Microscopic polyangiitis, Nephrology, EMA, Food, Steroid, Failure, European Medicines Agency, Degenerative disease, Receptor (biochemistry), Kidney, MAA, CEO, Granuloma, Disease, Conditional sentence, ANCA, NHI, History, Fresenius Medical Care, Neutrophil, European Commission, C5a, Inflammation, Cancer, Anti-neutrophil cytoplasmic antibody, End organ damage, Marketing, HS, MHLW, Infection, Time, Hidradenitis suppurativa, Kissei, Patient, GPA, Granulomatosis with polyangiitis, Atypical hemolytic uremic syndrome, Vifor Pharma, C5L2, MPA, Pharmaceutical industry, Vifor Pharma Group, Kissei Pharmaceutical Co., Ltd., ChemoCentryx Inc., ANCA-associated vasculitis, TAVNEOS® (avacopan), VIFOR PHARMA GROUP, KISSEI PHARMACEUTICAL CO., LTD., CHEMOCENTRYX INC., ANCA-ASSOCIATED VASCULITIS, TAVNEOS® (AVACOPAN)

ANCA-associated vasculitis is officially designated an intractable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required.

Key Points: 
  • ANCA-associated vasculitis is officially designated an intractable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required.
  • There is significant unmet medical need of over 10,000 patients in Japan, and we believe in the potential of TAVNEOS for treating it.
  • TAVNEOS demonstrated superiority over standard of care at week 52 based on Birmingham Vasculitis Activity Score (BVAS).
  • In June 2017, VFMCRP granted Kissei the exclusive right to develop and commercialize TAVNEOS in Japan.