Procollagen-proline dioxygenase

FibroGen Announces Outcome of FDA Advisory Committee Review of Roxadustat for Treatment of Anemia of Chronic Kidney Disease

Retrieved on: 
Thursday, July 15, 2021

Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by the FDA for review for the treatment of anemia of CKD.

Key Points: 
  • Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by the FDA for review for the treatment of anemia of CKD.
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia of chronic kidney disease (CKD).
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

Retrieved on: 
Friday, June 25, 2021

Todays positive CHMP opinion marks a significant step in providing patients with a new and important treatment option for anemia associated with CKD, regardless of dialysis status, saidBernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas.

Key Points: 
  • Todays positive CHMP opinion marks a significant step in providing patients with a new and important treatment option for anemia associated with CKD, regardless of dialysis status, saidBernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas.
  • We look forward to the review and assessment by the European Commission which, if positive, would make roxadustat the first HIF-PH inhibitor approved in Europe to treat symptomatic anemia in adult patients with CKD.
  • Roxadustat is also in Phase 3 clinical development for anemia associated with myelodysplastic syndromes (MDS) and Phase 2 for chemotherapy-induced anemia (CIA).
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).

Akebia Therapeutics Announces Presentations at ERA-EDTA Virtual Congress 2021

Retrieved on: 
Thursday, June 3, 2021

For more information on ERA-EDTA Virtual Congress 2021, visit: https://www.era-edta.org/en/virtualcongress2021/ .

Key Points: 
  • For more information on ERA-EDTA Virtual Congress 2021, visit: https://www.era-edta.org/en/virtualcongress2021/ .
  • Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease.
  • For more information, please visit our website at www.akebia.com , which does not form a part of this release.
  • Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against FibroGen Inc. (FGEN)

Retrieved on: 
Friday, May 14, 2021

You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.\nFibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer.

Key Points: 
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.\nFibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer.
  • Its most advanced product is roxadustat, an oral small molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase (\xe2\x80\x9cHIF-PH\xe2\x80\x9d) activity that acts by stimulating the body\xe2\x80\x99s natural pathway for red cell production.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • If you inquire by email please include your mailing address, telephone number and number of shares purchased.\nThis press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.\nGlancy Prongay & Murray LLP, Los Angeles\n'

FibroGen to Present at Upcoming Investor Conference

Retrieved on: 
Wednesday, April 28, 2021

A replay will be available for approximately 30 days.\nFibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics.

Key Points: 
  • A replay will be available for approximately 30 days.\nFibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics.
  • The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs.
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against FibroGen Inc. (FGEN)

Retrieved on: 
Monday, April 19, 2021

You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.\nFibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer.

Key Points: 
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.\nFibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer.
  • Its most advanced product is roxadustat, an oral small molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase (\xe2\x80\x9cHIF-PH\xe2\x80\x9d) activity that acts by stimulating the body\xe2\x80\x99s natural pathway for red cell production.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • If you inquire by email please include your mailing address, telephone number and number of shares purchased.\nThis press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210419005342/en/\n'

Otsuka and Akebia Announce Submission of New Drug Application to the FDA for Approval of Akebia’s Vadadustat

Retrieved on: 
Tuesday, March 30, 2021

In 2016, Otsuka and Akebia signed a collaboration and license agreement for vadadustat in the U.S.

Key Points: 
  • In 2016, Otsuka and Akebia signed a collaboration and license agreement for vadadustat in the U.S.
  • The two companies subsequently signed a collaboration and license Agreement in 2017 for vadadustat in certain other areas.
  • Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability.
  • Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI).

Akebia Therapeutics Announces Poster Presentations and Educational Symposium at National Kidney Foundation 2021 Virtual Spring Clinical Meetings

Retrieved on: 
Thursday, March 25, 2021

CAMBRIDGE, Mass., March 25, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it will present data at the National Kidney Foundation 2021 Spring Clinical Meetings (NKF SCM21), which takes place virtually April 6-10, 2021.

Key Points: 
  • CAMBRIDGE, Mass., March 25, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it will present data at the National Kidney Foundation 2021 Spring Clinical Meetings (NKF SCM21), which takes place virtually April 6-10, 2021.
  • Abstracts are now available online in the NKF SCM21 Abstract and ePoster Gallery: https://casehippo.com/spa/symposium/national-kidney-foundation-2021-spri... .
  • Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability.
  • In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

Global Chronic Kidney Disease Anemia Drug Forecast and Market Analysis 2021-2029: Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors Dominate the CKD Anemia Pipeline

Retrieved on: 
Monday, March 22, 2021

DUBLIN, March 22, 2021 /PRNewswire/ -- The "Chronic Kidney Disease Anemia - Global Drug Forecast and Market Analysis to 2029" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, March 22, 2021 /PRNewswire/ -- The "Chronic Kidney Disease Anemia - Global Drug Forecast and Market Analysis to 2029" report has been added to ResearchAndMarkets.com's offering.
  • Furthermore, the China CKD anemia market is expected to experience the highest growth, increasing to $962M (14.6% of global market share) by 2029, at a CAGR of 9.9%.
  • The CKD anemia market is relatively well-established; many physicians believe that the existing therapies, namely ESAs, effectively control anemia for most patients.
  • Major drivers of growth in the CKD anemia market over the forecast period include: the launch and uptake of novel hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) drug class across all markets covered in the report will drive the growth of the CKD anemia market.

FibroGen Provides Regulatory Update on Roxadustat

Retrieved on: 
Monday, March 1, 2021

While disappointed with the news today, FibroGen and AstraZeneca are committed to working with the FDA to bring roxadustat to patients with anemia of CKD in the U.S. as soon as possible, said Enrique Conterno, Chief Executive Officer, FibroGen.

Key Points: 
  • While disappointed with the news today, FibroGen and AstraZeneca are committed to working with the FDA to bring roxadustat to patients with anemia of CKD in the U.S. as soon as possible, said Enrique Conterno, Chief Executive Officer, FibroGen.
  • Roxadustat has been approved in China, Japan and Chile for the treatment of anemia of CKD in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.
  • Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by theFDAfor review for the treatment of anemia of CKD.
  • Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in review.