We use cookies on this website. The outcomes included a change in Hb levels from baseline (ΔHb) and all-cause mortality. Roxadustat is one of several prolyl-hydroxylase inhibitors (PHI), along with daprodustat, vadadustat, desidustat, and molidustat, that act by inhibiting hypoxia-inducible factor prolyl hydroxylase, stabilising HIF-α, increasing erythropoietin, and preventing its breakdown. The proportion of patients achieving Hb response at 2 consecutive visits without rescue during the first 24 weeks was 77.0% with roxadustat vs 8.5% with placebo (P <.001). Currently, 3 oral compounds—daprodustat, roxadustat, and vadadustat—have advanced to global phase 3 development for patients with chronic kidney disease (CKD) patients not on dialysis. AURYXIA ® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis. Akebia Therapeutics. Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease. Anaemia can be a serious medical condition in which patients have insufficient red blood cells and low levels of haemoglobin, a protein in red blood cells that carries oxygen to cells throughout the body. By using this site, you agree that we may store and access cookies on your device. AEs in both treatment groups were primarily mild or moderate in severity. Roxadustat Treatment for Anemia in Dialysis This randomized, phase 3 trial compared the effectiveness of roxadustat, an oral hypoxia-inducible factor … Phase III. No serious adverse event related to the study drug was considered. 21-23, 38 One of two RCTs of vadadustat reported increased incidence of hyperkalemia [7/138 (5%) vs 0/72 (0%) in vadadustat and control arms respectively]. Abstract; Full Text ; Full Text PDF; Scopus (103) Google Scholar; In 2 dose-finding studies, Provenzano et al. Moreover, vadadustat … Roxadustat is an emerging and promising therapeutic approach against anemia in CKD patients, which differs from those of conventional ESAs. (89.5% vs 78.0%), decrease in […] Read More. Vadadustat Performance vs. SOC ESA1 Roxadustat Statistically non-inferior HR=0.96 Statistically non-inferior HR=0.96 Statistically significant INCREASE p=0.001 Statistically significant DECREASE p = 0.0000003 • Both Fibrogen’s Roxadustat and Akebia’s Vadadustat were shown tobe non-inferior standard of care (ESA) with respect to the MACE outcome endpoint. Kidney Int. Pooled MACE/MACE+ in DD patients. The rates of serious adverse events were 13.0% in the vadadustat group and 10.6% in the DA group. In September 2019, Astellas had obtained an MA in Japan for the first oral HIF-PH inhibitor, roxadustat, and intended to launch the product in the UK (and elsewhere). Related Topics. There is a variety of reasons why trials in pediatric CKD patients may differ from adults. Vadadustat exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. OLYMPUS is a Phase III, randomized, double blind, placebo-controlled trial designed to evaluate the efficacy and safety of roxadustat vs. placebo for the treatment of … WARNINGS AND PRECAUTIONS. Share This Article . Vadadustat is the least potent inhibitor of PHD2, as the concentration needed to inhibit 50% of its activity in vitro (IC50) is the highest among the four compounds. Provenzano R. Besarab A. Daprodustat, Roxadustat, Vadadustat, and Molidustat are discussed in greater detail below. About anaemia. At the beginning, its indication was only limited to renal anemia in patients on dialysis. A mean blood pressure reduction of 2.6 ± 9.6 mm Hg from baseline was observed in the phase 2b trial of 16 and 24 weeks of treatment with roxadustat. The case began when Akebia and Otsuka sought to ‘clear the way’ for their HIF-PH inhibitor, vadadustat (which is currently in Phase III clinical trials). Another oral HIF-PHI drug – AstraZeneca and FibroGen’s roxadustat– has already been approved in China for CKD anaemia.Additional competition could come from Akebia, which has a drug in the class called vadadustat in late-stage clinical testing that is licensed to Mitsubishi Tanabe Pharma in some Asian markets including Japan. These experimental hypoxia-inducible factor prolyl hydroxylase inhibitors, roxadustat and vadadustat, aim to stimulate the body's endogenous erythropoietin, and have the advantage of being oral rather than infused intravenously as with the ESAs. See this table from a nice review Gupta et al, AJKD, 2017) for some key aspects of the different -dustats. FibroGen. PYRENEES was not included in the pooled CV safety analyses. Trial Results. Roxadustat demonstrated a mean increase from baseline in Hb levels, regardless of iron repletion, averaged over weeks 28 to 52 of 1.85 g/dL in pts treated with roxadustat vs. 0.13 g/dL with placebo (p<0.001). FibroGen has not even filed its AstraZeneca-partnered oral anemia drug roxadustat for U.S. regulatory approval. Vadadustat (INN; AKB-6548) is a drug which acts as a HIF prolyl-hydroxylase inhibitor and thereby increases endogenous production of erythropoietin, which stimulates production of hemoglobin and red blood cells.It is in Phase III clinical trials for the treatment of anemia secondary to chronic kidney disease.. See also. Vadadustat (AKB-6548, B-506, PG-1016548) is a novel, titratable, oral HIF-PH inhibitor. In the vadadustat group, the most common adverse events were nasopharyngitis (19.8% vs 28.6% in the DA group), diarrhea (10.5% vs 9.9% in the DA group), and shunt stenosis (8.0% vs 12.4% in the DA group). Find out more. Sun C.H. Chronic kidney disease is a global public health challenge that affects approximately 10% of … Vadadustat (INN) (AKB-6548) is a drug which acts as a HIF prolyl-hydroxylase inhibitor and thereby increases endogenous production of erythropoietin, which stimulates production of hemoglobin and red blood cells.It is in Phase III clinical trials for the treatment of anemia secondary to chronic kidney disease. With vadadustat nipping at roxadustat's heels, it would not be surprising to see all parties involved give timelines a boost. Related Companies. Three of the four roxadustat RCTs reported higher incidence rates of hyperkalemia [26/250 (10%) vs 6/109 (5.5%) in roxdustat and control groups respectively]. At weeks 24 to 36, vadadustat-treated patients demonstrated a mean Hb level of 10.36g/dL vs 10.53g/dL for darbepoetin alfa-treated patients. QUICK TAKE Roxadustat for Anemia in Chronic Kidney Disease 01:53. In November 2019, the novel drug for renal anemia, Roxadustat, became available for the first time in Japan. The percentage of patients who experienced ≥1 adverse event (AE) was comparable between the vadadustat and placebo groups (74.6% vs. 73.6%) . ID patients are a better population to compare roxadustat vs. epoetin alfa than the stable dialysis population, where patients are stable not only on dialysis but also on erythropoietin. Quality confirmed by NMR & HPLC. Compared with the placebo, there also was no significant association between the drugs and all-cause mortality (molidustat of RR, 0.39 [95 % CI, 0.06-2.59]; roxadustat, 0.40 (0.06-2.84); enarodustat, 0.33 (0.01-16.25); desidustat, 0.34 (0.01-17.00); epoetin, 0.50 (0.18-1.42); daprodustat, 0.54 (0.09-3.31); darbepoetin, 1.03 (0.65-1.65); and vadadustat, 1.43 (0.15-13.27)). To pass the regulators, however, roxadustat and vadadustat will need to show that they are at least as safe as ESAs. Occurrence of ≥1 drug-related AE was reported in 25.4% of vadadustat-treated patients (35 of 138) and 11.1% of placebo-treated patients (8 of 72). Vadadustat starting doses of 300 mg QD, 450 mg QD, and 450 mg TIW maintained mean Hb concentrations, from pre-baseline values to Weeks 7–8 and 15–16 in the prespecified primary efficacy analysis using observed data. Blood. Vadadustat is an oral, investigational hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development for the treatment of anemia related to chronic kidney disease. et al. Interventions of interest included 6 kinds of HIF-PHIs (Roxadustat, Daprodustat, Vadadustat, Molidustat, Desidustat, and Enarodustat) and 2 ESAs (Epoetin and Darbepoetin), comparisons of these different drugs, as well as placebos. HIMALAYAS evaluated roxadustat vs. epoetin alfa in ID patients; there were ID patients in ROCKIES and SIERRAS. Astellas (roxadustat), Akebia (vadadustat), GlaxoSmithKline (daprodustat), and Bayer (molidustat) have all deferred pediatric studies until phase III trials have been completed, which will allow changes to be made to the design of proposed studies, if needed. Subsequently, as of August 2020, daprodustat and vadadustat become available, which are indicated for both patients on dialysis and those in pre-dialysis stage. Vadadustat Vs Roxadustat From the randomized phase III study GOG 240, the US Food and Drug Administration (FDA) authorized the very first anti-angiogenic agent, bevacizumab (Avastin, Genentech/Roche), in mixture with chemotherapy for use in ladies with sophisticated cervical cancer [8]. 64 In an open-label phase 2b trial of roxadustat, the most frequent AE (10%) was hypertension requiring a modification to antihypertensive medication. 5. Shots: The P-III study involves assessing of Roxadustat (N=323) vs darbepoetin alfa (N=293) evaluating its safety and efficacy in (N=616) adult anemia patients with stage 3–5 chronic kidney disease (CKD) The study meet its 1EPs & 2EPs also demonstrated superiority, showing correction of hemoglobin levels during the first 24 wks. 2016; 90: 1115-1122. CONTRAINDICATION. Download PDF. See customer reviews, validations & product citations.
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