Nephrology

FDA Rejects Tricida’s NDA for Veverimer for Treatment of Metabolic Acidosis and Slowing of Kidney Disease Progression in Patients with Metabolic Acidosis Associated with CKD

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that it received a Complete Response Letter (CRL) from …

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FDA Accepts and Grants Priority Review to Aurinia’s NDA for Voclosporin for the Treatment of Lupus Nephritis

VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, …

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FDA Advisory Committee Votes to Recommend Terlipressin for Approval for Treatment of Hepatorenal Syndrome Type 1

DUBLIN, July 15, 2020 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted to recommend approval for its investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1) …

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Aurinia Completes Rolling Submission of Voclosporin NDA to the FDA for Treatment of Lupus Nephritis

VICTORIA, British Columbia & ROCKVILLE, Md.–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced the completion of the rolling submission of a New Drug Application (“NDA”) to the United States Food and Drug Administration …

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FDA Approves a Label Update for Lokelma to Include Dosing Guidance for Treatment of Hyperkalemia in ESRD on Hemodialysis

WILMINGTON, Del.–(BUSINESS WIRE)–Today, the US Food and Drug Administration (FDA) approved a label update in the US for AstraZeneca’s LOKELMA® (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalemia in patients with end-stage renal disease on chronic hemodialysis. The approval by the US FDA was based on positive results …

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Phase 3 Trial of Farxiga Will Be Stopped Early After Overwhelming Efficacy in Patients with Chronic Kidney Disease

WILMINGTON, Del.–(BUSINESS WIRE)–The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) Phase III trial for FARXIGA (dapagliflozin) in patients with chronic kidney disease (CKD) will be stopped early following a recommendation from an independent Data Monitoring Committee (DMC) based on its determination of overwhelming efficacy.   The decision to stop the trial early was made following …

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FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Kidney Disease

INGELHEIM, Germany, and INDIANAPOLIS, Ind.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of empagliflozin to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. The …

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GSK Announces Positive Headline Results in Phase 3 Study of Benlysta in Patients with Lupus Nephritis

GSK today announced positive headline results for intravenous (IV) Benlysta (belimumab) in the largest controlled phase 3 study in active lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE) which can lead to end-stage kidney disease. The Efficacy and Safety of Belimumab in Patients with …

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Aurinia’s Voclosporin Demonstrates Superiority Over Standard of Care in Phase 3 Lupus Nephritis Trial

VICTORIA, British Columbia–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) …

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Cara Therapeutics Announces Positive Topline Data from Mid-Stage Trial of Oral Korsuva in CKD Patients with Moderate-to-Severe Pruritus

STAMFORD, Conn., Dec. 03, 2019 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, today announced positive topline results from its Phase 2 dose-ranging trial of Oral KORSUVA™ (CR845/difelikefalin) …

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