Vadadustat

Akebia Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 11, 2024
Chronic kidney disease, Dialysis, Anemia, Patient, Kidney disease, Akebia, Food, Vadadustat, AKBA, PDUFA

CAMBRIDGE, Mass., March 11, 2024 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to report fourth quarter and full year 2023 financial results on March 14, 2024.

Key Points: 
  • CAMBRIDGE, Mass., March 11, 2024 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to report fourth quarter and full year 2023 financial results on March 14, 2024.
  • Akebia will not host a conference call due to the proximity to the anticipated March 27, 2024 Prescription Drug User Fee Act (PDUFA) target action date for vadadustat, which is under review by the U.S. Food and Drug Administration as a treatment for anemia due to chronic kidney disease in adult patients on dialysis.

Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease

Retrieved on: 
Wednesday, October 25, 2023
FDA, PDUFA, Food, AKBA, Vadadustat, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Chronic kidney disease, Dialysis, New Drug Application, Kidney disease, Anemia, NDA, CKD, Patient, Pharmaceutical industry, Akebia

CAMBRIDGE, Mass., Oct. 25, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the U.S. Food and Drug Administration (FDA) has acknowledged that the resubmission to its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis, was complete. The FDA has classified this as a class 2 response, which results in a six-month review period from the date of resubmission, and the FDA set a user fee goal date ("PDUFA" date) of March 27, 2024.

Key Points: 
  • The FDA has classified this as a class 2 response, which results in a six-month review period from the date of resubmission, and the FDA set a user fee goal date ("PDUFA" date) of March 27, 2024.
  • "We're extremely pleased the FDA acknowledged our resubmission to our NDA for vadadustat was complete following our productive interactions over the past year.
  • We look forward to working closely with the agency to finalize the review," said John P. Butler, Chief Executive Officer of Akebia.
  • Akebia's resubmission to its NDA addressed the issues raised in the complete response letter.

Akebia Therapeutics Resubmits New Drug Application to the FDA for Vadadustat

Retrieved on: 
Thursday, September 28, 2023
Chronic kidney disease, New Drug Application, NDA, AKBA, Dialysis, Patient, Anemia, PDUFA, FDA, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Vadadustat, Food, Kidney disease, Pharmaceutical industry, Akebia

Vadadustat is currently approved for use in 35 countries.

Key Points: 
  • Vadadustat is currently approved for use in 35 countries.
  • We look forward to working with the FDA during the review process and are eager to offer a new oral therapeutic to patients if approved."
  • Based on standard NDA resubmission review timelines, a letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the PDUFA date is expected in 30 days.
  • Akebia expects the FDA to set a PDUFA date of six months from the date of submission.

Akebia’s Vafseo (vadadustat) Poised to Make Waves for GSK’s Jesduvroq and FibroGen/Astellas’ Evrenzo

Retrieved on: 
Thursday, July 20, 2023
Anemia, GSK, Chronic kidney disease, Civil service commission, Myocardial infarction, ESA, Vadadustat, Stroke, NDA, Nephrology, Launch, Dialysis, Thrombosis, Coronary thrombosis, Patient, Physician, FDA, EC, CKD, Death, RealTime, European Commission, Daprodustat, Pharmaceutical industry, Medical device, EU, Roxadustat

While several agents within the class have found success globally, the U.S. struggled to get even just one approval across the finish line.

Key Points: 
  • While several agents within the class have found success globally, the U.S. struggled to get even just one approval across the finish line.
  • However, Jesduvroq’s approval did come with a black box warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
  • At the same time, their perceptions of ESAs as a treatment for renal anemia in dialysis patients have become increasingly favorable.
  • Assuming approval, Akebia’s launch of vadadustat will also be covered once commercially available and benchmarked against Jesduvroq at a similar time post-launch​.

FDA Provides Akebia Therapeutics a Path Forward for Vadadustat

Retrieved on: 
Tuesday, May 30, 2023
Mitsubishi Tanabe Pharma, Chronic kidney disease, Civil service commission, Symantec Endpoint Protection, Vadadustat, Rockwell Medical, Health care, Clinical trial, NDA, AKBA, Hepatotoxicity, Gross metropolitan product, Dialysis, European Commission, Division, Patient, European Economic Area, Risk, Anemia, OND, Medicines and Healthcare products Regulatory Agency, United Kingdom, Webcast, CRL, FDA, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CKD, Complete Response Letter, Food, Kidney disease, Safety, Medical device, Pharmaceutical industry, VAT, Akebia

The CRL raised a concern regarding the increased risk of thromboembolic events, driven by vascular access thrombosis (VAT).

Key Points: 
  • The CRL raised a concern regarding the increased risk of thromboembolic events, driven by vascular access thrombosis (VAT).
  • Accordingly, Akebia plans to include post-approval data from Japan in the NDA resubmission, where tens of thousands of Japanese patients with CKD have been exposed to vadadustat to date.
  • The OND's letter provides guidance on a path for the resubmission of our NDA and potential approval of vadadustat for dialysis dependent patients in the U.S. without suggesting the need to generate additional clinical data.
  • We appreciate the FDA's engagement with us throughout the appeal process," said John P. Butler, Chief Executive Officer of Akebia.

Akebia Therapeutics Enters into License Agreement with Medice Arzneimittel Pütter GmbH&Co.KG for the Commercialization of Vafseo® for the Treatment of Anemia associated with CKD in Europe and Australia

Retrieved on: 
Thursday, May 25, 2023
Chronic kidney disease, Vadadustat, Ministry of Health & Family Welfare (West Bengal), AKBA, Gross metropolitan product, Dialysis, Patient, European Economic Area, Anemia, United Kingdom, CKD, Kidney disease, Pharmaceutical industry, Rockwell Medical, Akebia

The exclusive license agreement grants Medice the rights to market and sell Vafseo in the European Economic Area in addition to the United Kingdom, Switzerland and Australia.

Key Points: 
  • The exclusive license agreement grants Medice the rights to market and sell Vafseo in the European Economic Area in addition to the United Kingdom, Switzerland and Australia.
  • Anemia associated with CKD, common in patients on dialysis, is a debilitating condition which may be associated with many adverse clinical outcomes.
  • Throughout Europe, we estimate that more than 325,000 dialysis patients are currently treated for anemia associated with CKD.
  • Vafseo is currently approved in Europe and the United Kingdom for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis.

Akebia Therapeutics Regaining Rights to Vadadustat in the United States, Europe, China and Access Consortium Countries upon Termination of Collaboration and License Agreements with Otsuka

Retrieved on: 
Thursday, June 30, 2022
Anemia, Erythropoietin, Review, FDA, Patient, European Medicines Agency, EPO, Adult, New Drug Application, Tissue, Dialysis, Endpoint security, Workforce, Mitsubishi Tanabe Pharma, MAA, Marketing, COVID-19, Company, Goal, Altitude, Mortality, Vadadustat, EMA, United Kingdom, Food, Oxygen, Lists of diseases, Dizziness, Fatigue, Chronic kidney disease, Nasdaq, Quality of life, Health, CKD, Risk, Kidney disease, Disease, Vifor Pharma, AKBA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Pharmaceutical industry, Fine chemical, Akebia

As part of the termination, Otsuka has agreed to pay Akebia a settlement fee of $55 million.

Key Points: 
  • As part of the termination, Otsuka has agreed to pay Akebia a settlement fee of $55 million.
  • "Otsuka has been a strong partner for many years, and we appreciate their desire to have an efficient transfer of the responsibilities back to Akebia.
  • Otsuka and Akebia will coordinate to transfer the MAA to Akebia through processes outlined by the EMA.
  • Vadadustat is also under review in the United Kingdom, Switzerland, and Australia through the Access Consortium.

High Unmet Needs Remain in Nephrology Despite Newly Approved Treatment Options According to Latest Research from Spherix Global Insights

Retrieved on: 
Thursday, June 30, 2022
FSGS, Vifor Pharma, FDA, IgA nephropathy, Nephrology, Patient, Adoption, Dialysis, DKD, AKI, Acute kidney injury, Immunoglobulin A, Vadadustat, Advisory Committee, Hyperphosphatemia, Kidney disease, Awareness, Benchmarking, Anemia, Perception, HIF, Polycystic kidney disease, Alport syndrome, Organization, Lupus nephritis, CKD, Reata Pharmaceuticals, Fresenius Medical Care, DaVita Inc., Physician, FMC, PKD, Pharmaceutical industry, Roxadustat

EXTON, Pa., June 30, 2022 /PRNewswire/ -- A survey of 124 US nephrologists, conducted just last week, identifies acute kidney injury (AKI), diabetic kidney disease (DKD), and polycystic kidney disease (PKD) as areas physicians would most like to see new products approved to treat patients under their care. New agents for glomerular diseases, including focal segmental glomerulonephritis (FSGS) and IgA nephropathy (IgAN) are also in high demand.

Key Points: 
  • New agents for glomerular diseases, including focal segmental glomerulonephritis (FSGS) and IgA nephropathy (IgAN) are also in high demand.
  • In prior Spherix research, following the receipt of these CRLs, many nephrologists expressed disappointment about the non-approval of the HIF-PH inhibitors, which are approved in countries outside the US, and tenapanor.
  • Korsuva, for CKD-associated pruritus in hemodialysis patients, is the newest approved renal product that Spherix is tracking.
  • Korsuva was originally approved in August of 2021; however, the product didn't officially launch until this past spring.

Bronstein, Gewirtz & Grossman, LLC Reminds Akebia Therapeutics, Inc. (AKBA) Shareholders of Class Action Final Deadline and Last Few Hours to Actively Participate

Retrieved on: 
Friday, May 13, 2022
Defendant, Patient, NASDAQ, Review, Therapy, NDD, Complaint, Lists of schools in England, Court, Vadadustat, Anemia, Person, LLC, GLOBE, AKBA, Akebia

This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws.

Key Points: 
  • This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws.
  • The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and prospects.
  • or his Investor Relations Analyst, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484.
  • If you suffered a loss in Akebia you have until May 13, 2022, to request that the Court appoint you as lead plaintiff.

AKBA FINAL DEADLINE FRIDAY: ROSEN, TRUSTED NATIONAL TRIAL COUNSEL, Encourages Akebia Therapeutics, Inc. Investors with Losses to Secure Counsel Before Important May 13 Deadline in Securities Class Action – AKBA

Retrieved on: 
Tuesday, May 10, 2022
Titan, WHY, Twitter, TO, NASDAQ, Advertising, I-Space (Chinese company), Patient, Anemia, Court, Facebook, Class, Lists of schools in England, LinkedIn, AKBA, NDD, Vadadustat, THE, Therapy, Insurance, Tobacco, Akebia

WHAT TO DO NEXT: To join the Akebia class action, go to https://rosenlegal.com/submit-form/?case_id=4028 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Akebia class action, go to https://rosenlegal.com/submit-form/?case_id=4028 or call Phillip Kim, Esq.
  • If you wish to serve as lead plaintiff, you must move the Court no later than May 13, 2022.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.