chronic kidney disease

Recent Inclination of Pharma Companies, Emerging Pipeline Therapies Drive the IgA Nephropathy Market Share Growth

Chronic diseases (CDs) pose a significant challenge to healthcare in the 21st century. Factors such as population aging, lifestyle-modifiable risk factors, a decline in early-life infectious diseases, sedentary lifestyle, unhealthy food habits have resulted in the emergence of chronic diseases as a major global health threat. Among CDs, Chronic kidney disease (CKD) is particularly of …

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FDA approves first drug for severe itching in chronic kidney disease patients

Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the FDA’s nod green light for its injectable drug, Korsuva.

Cara’s Korsuva is first drug cleared for itching in dialysis patients

One of the most common and challenging side effects for people undergoing dialysis for chronic kidney disease – chronic itching – now has an FDA-approved treatment. The US regulator has cleared Cara Therapeutics’ Korsuva (difelikefalin) as an injectable treatment for chronic itching, also known as pruritus, in these patients after a priority review. The green …

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After FDA snub, EMA backs FibroGen, Astellas’ roxadustat

The EU regulator has approved  FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. The decision makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for use in the EU, ahead of rival candidates daprodustat from …

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FDA rejects FibroGen/AZ’s roxadustat, asking for new trial

The FDA has demanded another clinical trial of FibroGen and AstraZeneca’s roxadustat for anaemia caused by chronic kidney disease (CKD) before it will consider approval, setting up a lengthy delay to the programme. The need for a new trial is something of a worst-case scenario for roxadustat, although a rejection was expected after an FDA …

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AZ gets European approvals for Forxiga in chronic kidney disease

AstraZeneca’s Forxiga has become the first SGLT2 inhibitor to be approved in Europe for use in people with chronic kidney disease, extending its lead over rival drugs in the class. The European Commission has cleared Forxiga (dapagliflozin) for CKD in adults with or without diabetes, and the drug becomes the first new drug treatment for …

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FDA turns down Ardelyx’s chronic kidney disease drug and asks for another trial

Ardelyx drug tenapanor was rejected by the FDA as a treatment for a complication experienced by chronic kidney disease patients. The regulatory decision came two weeks after the company received an FDA letter citing deficiencies in the drug application.

Hard times at Ardelyx as FDA rejects kidney disease drug tenapanor

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. The US regulator had extended its review of the drug by three months – setting …

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GSK Reports Results of Daprodustat in P-III ASCEND Program for the Treatment of Anemia due to Chronic Kidney Disease

Shots: The P-III ASCEND program includes 5 studies i.e ASCEND-ND, D, ID, NHQ & TD studies evaluating efficacy & safety of daprodustat vs ESA in ~8,000 patients with anemia due to CKD for ~ 3.75yrs. The program met its 1EPs in 5 studies i.e improvement in Hgb levels in untreated patients and maintaining Hgb levels …

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FDA adcomm turns down FibroGen, AZ’s roxadustat for CKD anaemia

Safety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca’s roxadustat for anaemia associated with chronic kidney disease (CKD) in the US, after FDA advisors voted comprehensively against the drug yesterday. Just one of the 14-member panel thought that roxadustat should be approved for non-dialysis-dependent CKD patients, and only …

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Bayer’s finerenone gets FDA nod for diabetic kidney disease

Bayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff competition in the market.  The oral, non-steroidal mineralocorticoid receptor (MR) antagonist has been approved as Kerendia in the US – its first world market …

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Bayer kidney disease drug gets FDA nod, pitting it against AstraZeneca, J&J meds

The FDA has approved Bayer’s Kerendia to treat chronic kidney disease in patients with type 2 diabetes. The drug is the first in its class, giving the pharma giant an alternative way to compete against medicines already marketed by AstraZeneca and Bayer.

Novo Nordisk moves chronic kidney disease drug ziltivekimab into phase 3

Novo Nordisk has announced plans to move its ziltivekimab into phase 3 clinical development in atherosclerosis with chronic kidney disease after a mid-stage trial met its main goal. The Danish pharma said the phase 2 RESCUE trial showed a significant reduction of several inflammatory biomarkers associated with atherosclerosis in people with advanced chronic kidney disease …

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Bayer Reports Results of Finerenone in P- III FIGARO-DKD CV Outcomes Study for Chronic Kidney Disease and Type 2 Diabetes

Shots: The P-III FIGARO-DKD study involves assessing the efficacy and safety of finerenone (10/20mg, PO, qd) + SoC vs PBO + SoC in ~7400 patients with CKD and T2D at 1,000+ sites across 47 countries globally The study resulted in meeting its 1EPs i.e reduction in the composite risk of time to the first occurrence …

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AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA

AstraZeneca is already seeing sales rocket for its SGLT2 inhibitor Farxiga in heart failure, and is expected to gather even more momentum after claiming FDA approval in chronic kidney disease (CKD).  The US regulator has cleared Farxiga (dapagliflozin) to reduce the risk of kidney damage, end-stage kidney disease, cardiovascular, death and hospitalisation for heart failure …

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AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Approval for Chronic Kidney Disease

Shots: The approval is based on P-III DAPA-CKD trial assessing Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/out T2D Results: 39% reduction in relative risk of worsening of renal function or risk of CV or renal death, ARR (5.3%) @2.4yrs., and reduction …

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AstraZeneca Selects AI-Generated CKD Target Under its Collaboration with BenevolentAI

Shots: AstraZeneca has selected a novel CKD target to advance to its drug development portfolio, making it the first AI-generated target from the collaboration to enter its portfolio In 2019, companies collaborated to discover new drugs for CKD and IPF The collaboration leverages AstraZeneca’s scientific expertise and rich datasets with BenevolentAI’s target identification platform to …

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Bayer’s Finerenone Demonstrates Positive Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

Shots: The P-III FIDELIO-DKD study in CKD and T2D enrolled over 13,000 patients with early kidney damage and more advanced stages of kidney disease. The data were presented at the ASN Kidney Week 2020 and published in the NEJM based on which Bayer submitted finerenone for marketing authorization in the US and the EU Results: …

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Bayer data for kidney disease hope finerenone sets up filings

Bayer’s blockbuster ambitions for diabetic kidney disease (DKD) drug candidate finerenone look a lot firmer with the publication of data from the phase 3 FIDELIO-DKD trial. Bayer teased the top-line result from the study back in July, providing the first clue that its sizeable investment in the finerenone programme could pay off, but kept the …

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Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week

Shots: The global program includes two P-III studies assessing vadadustat (PO) vs darbepoetin alfa (inj.) in a ratio (1:1) in incident dialysis patients (Correction/Conversion) and prevalent dialysis patients (Conversion), in ~3,923 adult patients on dialysis with anemia due to CKD The presentation expands on previously reported positive data showing vadadustat achieved clear and consistent results …

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AstraZeneca’s Farxiga Receives the US FDA’s Breakthrough Therapy Designation for Chronic Kidney Disease

Shots: The BT destination follows P-lll DAPA-CKD assessing Farxiga (10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2-4 and elevated urinary albumin excretion, with/ out T2D across 21 countries Results: 39% reduction in the composite measure of worsening of renal function or risk of CV or renal death; 31% reduction in …

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Novo Nordisk Collaborates with Evotec to Develop Therapies Targeting Chronic Kidney Disease

Shots: Evotec to receive $179M/ product as upfront, research funding and milestones along with the royalties on sales of the therapies while Novo Nordisk will lead the clinical development and commercialization of the therapies The companies will share responsibilities during drug discovery and pre-clinical development and will jointly identify and develop novel targets based on …

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AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Shots: The P-III DAPA-CKD involve assessing of Farxiga ((dapagliflozin, 10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2–4 and elevated urinary albumin excretion, with and without T2D The study met its 1EPs i.e. worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, the …

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Trial shows AZ’s Farxiga slows onset of chronic kidney disease and cuts mortality

AstraZeneca’s Farxiga could be on course for another use, after trial results showed it slowed the worsening of renal function and cut the risk of death in patients with chronic kidney disease with and without type 2 diabetes. Farxiga (dapagliflozin), an oral once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor, started life as a diabetes drug but AZ has …

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