Overdose

Statement from Akebia Therapeutics Regarding Litigation Against Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services

Retrieved on: 
Monday, October 25, 2021
Cough, BIO, IV, Iron, Organization, Hyperphosphatemia, HHS, American Kidney Fund, Nausea, Dialysis, TSAT, Pregnancy, Lactation, Birth, United States Court of Appeals for the First Circuit, Transferrin, Therapy, Centers for Medicare & Medicaid Services, Risk, CMS, National Kidney Foundation, Gestational diabetes, Miscarriage, Constipation, Hyperkalemia, Overdose, Abdominal pain, Goal, Milk, Medicare Part D, Biotechnology Innovation Organization, Infant, Office of Inspector General, U.S. Department of Health and Human Services, Center, Chronic kidney disease, Medicare, Accidental, CKD, List, Patient, Health equity, FDA, Congress, Time, Vomiting, Adult, IDA, Nephrology, Kidney disease, Pharmaceutical industry, Health insurance, Vaccine

We also asked the federal district courttoissue an injunction to immediately restorecoverageforAuryxiawhen used forIDA while the lawsuit was pending.

Key Points: 
  • We also asked the federal district courttoissue an injunction to immediately restorecoverageforAuryxiawhen used forIDA while the lawsuit was pending.
  • Unfortunately, thefederal district courtdeniedour motionforapreliminaryinjunctionand the U.S. Court of Appeals for the First Circuit affirmed the district court's decision.
  • All eligible patients deserve access to, and Medicare coverage for, critical, innovative therapies such as Auryxia for chronic kidney disease.
  • However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation.

Akebia Announces Vadadustat Efficacy and Safety Data to be Presented at American Society of Nephrology Kidney Week 2021

Retrieved on: 
Monday, October 18, 2021
Miscarriage, Patient, Pregnancy, Infant, Goal, Anemia, Constipation, Altitude, CKD, Labour, Risk, Iron, NDA, Adult, Lactation, Birth, MHLW, Hyperkalemia, Tissue, Abdominal pain, Dialysis, New Drug Application, Marketing, Nausea, FDA, Transferrin, Hyperphosphatemia, Gestational diabetes, Kidney disease, Cough, Overdose, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TSAT, Food, U.S. Securities and Exchange Commission, Oxygen, Chronic kidney disease, Milk, Review, IV, Vomiting, Private Securities Litigation Reform Act, Safety, Therapy, Accidental, Pharmaceutical industry, Vaccine

Vadadustat is an investigational new drugandis not approved by theFDA or any regulatory authority with the exception ofJapan'sMinistry ofHealth, Labour and Welfare(MHLW).

Key Points: 
  • Vadadustat is an investigational new drugandis not approved by theFDA or any regulatory authority with the exception ofJapan'sMinistry ofHealth, Labour and Welfare(MHLW).
  • InJapan,vadadustatis approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.
  • Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease.
  • Akebia Therapeutics and Auryxia are registered trademarks of Akebia Therapeutics, Inc. and/or its affiliates.