Hyperphosphatemia

XPHOZAH® (tenapanor) Granted Orphan Drug Designation by U.S. FDA for the Treatment of Pediatric Hyperphosphatemia

Retrieved on: 
Wednesday, November 15, 2023
Chronic kidney disease, Hyperphosphatemia, China Biologic Products, Orphan, Patient, Dialysis, Food, CKD, FDA, Pharmaceutical industry

WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.

Key Points: 
  • WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.
  • XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
  • “We are pleased that the FDA has recognized the important need among pediatric patients with hyperphosphatemia for treatment options,” said Mike Raab, president and chief executive officer of Ardelyx.
  • In October, XPHOZAH was approved by the FDA to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

Unicycive Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
NDA, Chronic kidney disease, Hyperphosphatemia, Chemistry, Food, Therapy, Type, IND, Kidney disease, Clinical trial, Administration, Insurance, Patient, LOS, Agency, Research, Dialysis, FDA, Pharmacokinetics, Nephrology, Trial of the century, R, CMC, Research and development, Doctor of Philosophy, American Journal, Society, Travel, Drug development, Pharmaceutical industry, Management, OLC

LOS ALTOS, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.
  • We also remain very active within the the medical community with a booth at Kidney Week and positive results published on the phosphate binding capacity for OLC,” concluded Dr. Gupta.
  • Unicycive believes that results from this pivotal trial will enhance the OLC data package from preclinical studies and our previously disclosed bioequivalence study.
  • Dr. Kenkare-Mitra brings Unicycive expertise spanning research, preclinical and clinical development, translational medicine, manufacturing, and regulatory.

Ardelyx Announces XPHOZAH® (tenapanor) Now Available in the United States

Retrieved on: 
Monday, November 6, 2023
Chronic kidney disease, CKD, Dialysis, Patient, Kidney, Hyperphosphatemia, Pharmacy, Pharmaceutical industry, Hospital

WALTHAM, Mass., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced XPHOZAH is now available for shipment to partner pharmacies. XPHOZAH® (tenapanor) is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.

Key Points: 
  • WALTHAM, Mass., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced XPHOZAH is now available for shipment to partner pharmacies.
  • XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
  • Ardelyx will integrate XPHOZAH into its established patient services program, ArdelyxAssist™.
  • ArdelyxAssist is an innovative, digital-forward patient services program that provides access and affordability support for patients, with integration into medical office work processes and connectivity to patients and health care providers.

Ardelyx Shares Positive Data from Studies of XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor, at ASN Kidney Week 2023

Retrieved on: 
Friday, November 3, 2023
Spotlight, Education, Incidence, Food, Diarrhea, Sevelamer, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, American Society of Nephrology, SAE, Chronic kidney disease, Quality of life, Dialysis, ASN, Kidney disease, Peritoneal dialysis, CKD, Safety, Kidney, Hospital, Pennsylvania Convention Center, Cohort, Memory, Pharmaceutical industry, Phosphorus, Patient, MD, Hyperphosphatemia, Nephrology

Ardelyx’s presence at Kidney Week 2023 will honor the memory of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and a passionate advocate for patients with kidney disease.

Key Points: 
  • Ardelyx’s presence at Kidney Week 2023 will honor the memory of Derek Forfang, Chair of the Ardelyx Patient Advisory Council and a passionate advocate for patients with kidney disease.
  • XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily.
  • Additionally, Ardelyx is hosting an XPHOZAH Exhibitor Spotlight at ASN Kidney Week 2003.
  • Director of Home and Peritoneal Dialysis Programs, Boise Kidney & Hypertension Institute, and by David Spiegel, MD, Vice President of Nephrology at Ardelyx.

Ardelyx Reports Third Quarter 2023 Financial Results and Updates 2023 U.S. IBSRELA® Net Sales Revenue Guidance

Retrieved on: 
Tuesday, October 31, 2023
Rat, Research, Constipation, American College, Food, Northside Hospital, Prescription, Dehydration, Risk, New Drug Application, CKD, Human, Sale, MPH, Diarrhea, Jefferies Group, Journal, Chronic kidney disease, Irritable bowel syndrome, NDA, Safety, App, Investment, Patient, D, Fosun Pharma, IBS-C, Hyperphosphatemia, ACG, Growth, Clinical trial, SLR, Kyowa Kirin, FDA, Incidence, Conversation, Regulation of tobacco by the U.S. Food and Drug Administration, American College of Gastroenterology, Society, Death, Abdominal distension, Dialysis, Pharmaceutical industry, Fine chemical, Beauty salon, Video game, Nursing, Birth control, Health, Motility, RD

WALTHAM, Mass., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • “Demonstrating consistent, quarter-over-quarter growth of IBSRELA prescriptions during the third quarter, we achieved a 22 percent increase in net sales revenue.
  • We have raised our full year U.S. net sales revenue guidance for IBSRELA, reflecting the important benefit this product is offering to patients.
  • Driven by increased demand for IBSRELA, the company reported net sales revenue of $22.3 million in the third quarter, 22 percent quarter-over-quarter growth compared to the second quarter of 2023.
  • Ardelyx currently expects full-year 2023 U.S. net product revenue for IBSRELA to be between $76.0 and $78.0 million.

FDA Approves XPHOZAH® (tenapanor), a First-in-Class Phosphate Absorption Inhibitor

Retrieved on: 
Wednesday, October 18, 2023
FDA, ET, Stanford University, Food, Hyperphosphatemia, Diarrhea, Physician, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Kidney, Maintenance, Phosphorus, Chronic kidney disease, Dialysis, Clinical trial, Medicine, CKD, Safety, Patient, Pharmaceutical industry

WALTHAM, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has approved XPHOZAH® (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.

Key Points: 
  • XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
  • It is also a significant accomplishment for everyone at Ardelyx,” said Mike Raab, president and chief executive officer of Ardelyx.
  • XPHOZAH is a phosphate absorption inhibitor.
  • In patients not adequately responding to phosphate binder therapy, XPHOZAH has been shown to help increase the proportion of patients achieving target serum phosphate concentrations.

American Regent Introduces Potassium Phosphates, USP; FDA-Approved and "AP" Rated¹

Retrieved on: 
Thursday, October 19, 2023
Cardiac arrest, ECG, Injection, Seizure, Arrhythmia, Nephrocalcinosis, Hypercalcaemia, Infant, Kidney, Continuity, Risk, Hyperkalemia, Death, Parenteral nutrition, Child, Potassium, Lactation, Thrombosis, Acute kidney injury, Milk, Tetany, Toxicity, Phosphate, Patient, Central nervous system, Bolus, Hyperphosphatemia, Hypophosphatemia, Hypotension, Hypocalcemia, Tubing (recreation), Pulmonary embolism, Use, Aluminium, Administration, Late preterm infant, QT, Calcium, Ketoacidosis, Phosphorus, Birth control, Medical device, Pharmaceutical industry, Magnesium deficiency

In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid "IV push" has resulted in cardiac arrest, cardiac arrhythmias, hypotension, and death.

Key Points: 
  • In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid "IV push" has resulted in cardiac arrest, cardiac arrhythmias, hypotension, and death.
  • Vein Damage and Thrombosis: Potassium Phosphates Injection must be diluted and administered in intravenous fluids or used as an admixture in parenteral nutrition.
  • You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
  • You are encouraged to report adverse drug events (ADEs) to American Regent:
    ADEs may also be reported to the FDA:

Akebia Therapeutics Announces Five Poster Presentations at ASN Kidney Week 2023

Retrieved on: 
Wednesday, October 18, 2023
Patient, Burden, PDUFA, Food, Booth, ESKD, EST, AKBA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Poster, Society, Abstract (summary), Chronic kidney disease, Convention, National Primate Research Exhibition Hall, New Drug Application, Kidney disease, Anemia, Kidney, Pennsylvania Convention Center, Pharmaceutical industry, Akebia, Hyperphosphatemia, Dialysis

CAMBRIDGE, Mass., Oct. 18, 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 that it will present data at the American Society of Nephrology Kidney Week 2023 (ASN Kidney Week), which will take place at the Pennsylvania Convention Center in Philadelphia from November 2-5, 2023.

Key Points: 
  • CAMBRIDGE, Mass., Oct. 18, 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 that it will present data at the American Society of Nephrology Kidney Week 2023 (ASN Kidney Week), which will take place at the Pennsylvania Convention Center in Philadelphia from November 2-5, 2023.
  • Akebia-supported posters will be presented at ASN Kidney Week on November 2, 2023, from 10:00 a.m. – 12:00 p.m. EST.
  • ASN Kidney Week attendees can also visit Akebia at Booth #2515 in the Exhibit Hall.
  • Notably, Akebia will present a poster with data on alternate dosing for vadadustat, its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia due to chronic kidney disease in adult patients on dialysis.

Ardelyx to Present Data Updates for XPHOZAH (tenapanor) for Hyperphosphatemia at Kidney Week 2023 November 1-5 in Philadelphia, PA

Retrieved on: 
Friday, October 13, 2023
Abstract, Society, Kyowa Kirin, Hyperphosphatemia, ASN, American Society of Nephrology, Patient, Pharmaceutical industry

WALTHAM, Mass., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced upcoming data presentations for tenapanor for hyperphosphatemia at the American Society of Nephrology (ASN) Kidney Week 2023 meeting to be held in Philadelphia, PA, November 1-5, 2023.

Key Points: 
  • WALTHAM, Mass., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced upcoming data presentations for tenapanor for hyperphosphatemia at the American Society of Nephrology (ASN) Kidney Week 2023 meeting to be held in Philadelphia, PA, November 1-5, 2023.
  • XPHOZAH (tenapanor), discovered and developed by Ardelyx, is an investigational first-in-class phosphate absorption inhibitor.
  • Information regarding ASN's Kidney Week, including copies of presentation abstracts, can be found at https://www.asn-online.org/education/kidneyweek .
  • Title: Optimal Initiation of Tenapanor Treatment Analyzed by Baseline Phosphate Binder Dose: A Sub-analysis of the OPTIMIZE Study

Tenapanor for Hyperphosphatemia Approved in Japan

Retrieved on: 
Monday, September 25, 2023
Chronic kidney disease, MHLW, Serum, New Drug Application, NDA, Kyowa Kirin, Dialysis, Patient, Nephrology, Hyperphosphatemia, FDA, Phosphorus, CKD, Safety, TSE, Pharmaceutical industry, Health

WALTHAM, Mass., Sept. 25, 2023 (GLOBE NEWSWIRE) --  Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin), has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the New Drug Application (NDA) for tenapanor for the improvement of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis. Tenapanor will be marketed with the brand name PHOZEVEL® in Japan.

Key Points: 
  • “The approval of tenapanor for hyperphosphatemia in Japan is a historic moment for Ardelyx and CKD patients on dialysis.
  • The NDA in Japan was supported by data from four Phase 3 clinical trials, conducted in Japan by Kyowa Kirin in patients with hyperphosphatemia on maintenance dialysis.
  • The results of the studies undertaken by Kyowa Kirin suggested that tenapanor may also reduce the medication burden of phosphorus management utilizing marketed phosphate binders in combination with tenapanor or tenapanor alone for treating hyperphosphatemia.
  • In these studies, the safety and tolerability profile for tenapanor was consistent with prior studies in Japan.