Vadadustat was also associated with significant decreases in ferritin at all dose levels and hepcidin levels at doses of 370, 500, and 630 mg/day (p < 0.05) [20]. 10 Mar 2020. https://akebia.com/. CAS  Vadadustat received its first approval on June 29 2020 for anaemia associated with CKD in Japan [4]. It is subject to approval of vadadustat by the FDA and inclusion of vadadustat in a bundled reimbursement model, upon which Akebia will receive a $20 million payment from Vifor Pharma. Effect of moderate hepatic impairment on pharmacokinetics of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) [abstract no. Hepatic dysfunction with elevated AST, ALT and total bilirubin levels may also occur [5]. Eighty, 73 and 68% of patients in the 300 mg once daily, 450 mg once daily, and 450 mg thrice weekly cohorts, respectively, completed the study. The mean haemoglobin level between weeks 40 and 52 was 10.51 g/dL in the vadadustat group versus 10.55 g/dL in darbepoetin alfa recipients (LSM difference between groups − 0.07 g/dL; 95% CI − 0.34 to 0.19) [6]. Découvrez comment nous utilisons vos informations dans notre Politique relative à la vie privée et notre Politique relative aux cookies. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy, Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand, You can also search for this author in Article  PubMed Google Scholar. 5 May 2020. https://akebia.com/. Am J Kidney Dis. Mitsubishi Tanabe Pharma Corporation. Significant, dose-dependent changes in biomarkers of iron utilisation and mobilization (total iron binding capacity increased; transferrin saturation, mean absolute ferritin and hepcidin decreased) were evident after 16 weeks of vadadustat treatment in all groups. Roxadustat is under FDA review as an oral medicine to treat anemia caused by chronic kidney disease, both in patients who need dialysis and those who don't. 2020. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/400315_39990D3F1020_1_01. Pour autoriser Verizon Media et nos partenaires à traiter vos données personnelles, sélectionnez 'J'accepte' ou 'Gérer les paramètres' pour obtenir plus d’informations et pour gérer vos choix. 2019;26(4):253–66. The LSM change in haemoglobin levels from pretreatment to week 6 was 0.43, 1.13 and 1.62 g/dL in the vadadustat 150, 300, and 600 mg/day groups versus − 0.47 g/dL in the placebo group (all p < 0.01 vs. placebo). A. Markham is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. Anthony Markham. 4 Jan 2016. https://akebia.com/. The trial was evaluating the company’s vadadustat for treatment of anemia caused by chronic kidney disease in adults not on dialysis. Correspondence to Akebia Therapeutics Inc. Akebia and Otsuka expand relationship with collaboration to develop and commercialise vadadustat in Europe, China and other territories [media release]. PubMed Central  In total, 60% surveyed US nephrologists anticipated an FDA approval for vadadustat, while 40% saw a US approval in this patient population as unlikely. Randomized, open-label, active-controlled (darbepoetin alfa), phase 3 study of vadadustat for treating anemia in non-dialysis-dependent CKD patients in Japan [abstract no. BPRL PRIVATE LIMITED | Herbal Division | Super speciality Division . Nephrol Dial Transplant. Vadadustat is in global Phase 3 development for the treatment of anemia due to CKD and is not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority with the exception of Japan's Ministry of Health, Labour and Welfare (MHLW). Akebia Therapeutics Inc. Akebia closes $41 million Series C [media release]. It is subject to approval of vadadustat by the FDA and inclusion of vadadustat in a bundled reimbursement model, upon which Akebia will receive a $20 million payment from Vifor Pharma. Vadadustat: First Approval Vadadustat (VAFSEO^®) is a prolyl hydroxylase inhibitor being developed by Akebia Therapeutics, Inc. (Akebia) for the treatment of anaemia associated with chronic kidney disease (CKD). 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. 71.4% of patients who had received vadadustat for 16 weeks had a haemoglobin level within the target range of 10–12 g/dL. Akebia's revenue from the profit share and the milestone payment will be shared with Otsuka Pharmaceutical Co. Ltd., Akebia's U.S. collaborator. In INNO2VATE-conversion, patients on chronic dialysis who were receiving recombinant ESAs (n = 3554) were randomly switched to vadadustat or darbepoetin alfa (n = 1777 per cohort). Yeh TL, Leissing TM, Abboud MI, et al. Markham, A. Vadadustat: First Approval. Adverse events considered serious included cerebral infarction, occurring in 0.4% of patients, and shunt occlusion, occurring in 1% of patients (the Japanese prescribing information contains a warning about the risk of thromboembolism). Google Scholar. In this trial, patients were randomized to treatment with vadadustat 150 mg (n = 15), 300 mg (n = 15) and 600 mg (n = 14) or placebo (n = 14) once daily for 6 weeks, followed by a 10-week dose adjustment/maintenance phase (vadadustat dosages were adjusted to achieve a target haemoglobin of 10–12 g/dL; placebo recipients were switched to vadadustat 150, 300 or 600 mg/day) [19]. 2017;8(11):7651–68. Chem Sci. Vadadustat improved mean haemoglobin levels from 10.68 g/dL at baseline to 11.27 g/dL at week 24 in patients converted from other ESAs (n = 80) and from 10.17 to 11.85 g/dL in patients who were not receiving ESAs at baseline (n = 71) [17]. 2019;30:212. Accessed 21 Jul 2020. 14 Dec 2015. https://akebia.com/. Impaired renal or hepatic function had no clinically relevant effect on the pharmacokinetic profile of vadadustat [5, 15] and there were no clinically relevant changes in exposure to vadadustat when the drug was administered with food [16]. Vadadustat is a substrate for organic anion transporters (OAT) 1 and 3, and has an inhibitory effect on breast cancer resistance protein (BCRP) and OAT3. Yahoo fait partie de Verizon Media. Those occurring in < 1% of patients included sleep disorders, somnolence, retinal haemorrhage, vertigo, palpitations, polycythaemia, abdominal discomfort, vomiting, loose stools, gastritis, gastroenteritis, stomatitis, rash, pruritus, eczema, erythema, alopecia, cold sweats, frequent urination, increased blood creatinine levels, malaise, chest discomfort, nipple pain and peripheral oedema [5]. Kidney Int. INNO2VATE-correction/conversion (NCT02865850) enrolled incident dialysis patients who had initiated peritoneal dialysis or haemodialysis ≤ 16 weeks prior to screening and had limited exposure to recombinant ESAs. This profile has been extracted and modified from the AdisInsight database. In a further phase II trial (NCT02260193) conducted in the USA, vadadustat maintained mean haemoglobin concentrations in patients on haemodialysis who had previously received epoetin [22]. Informations sur votre appareil et sur votre connexion Internet, y compris votre adresse IP, Navigation et recherche lors de l’utilisation des sites Web et applications Verizon Media. 2019;34(1):90–9. The difference in LSM haemoglobin levels between the two groups was − 0.05 g/dL (95% CI − 0.26 to 0.17) with the lower limit of the 95% confidence interval exceeding the predefined noninferiority margin of − 0.75 g/dL. Article  The preparation of this review was not supported by any external funding. Nangaku M, Kondo K, Kokado Y, et al. Preclinical characterization of vadadustat (AKB-6548), an oral small molecule hypoxia inducible factor prolyl-4-hydroxylase inhibitor, for the potential treatment of renal anemia [abstract no. 2020. https://doi.org/10.1093/ndt/gfaa060. In the per-protocol population, 54.9% of patients on vadadustat and 10.3% of patients on placebo achieved or maintained either a mean haemoglobin level of  ≥ 11.0 g/dL or a mean increase in haemoglobin of ≥ 1.2 g/dL over the predose average during the last 2 weeks of treatment (primary endpoint). Vadadustat was noninferior to darbepoetin alfa in the time to first MACE (HR 0.96; 95% CI 0.83–1.11) in a combined analysis of data from both INNO2VATE trials [6]. Drugs 80, 1365–1371 (2020). Vadadustat is primarily metabolized by glucuronidation and O-glucuronic acid conjugates accounted for a further ≈ 15% of radioactivity [5]. TH-PO369]. Vadadustat is in global Phase 3 development for the treatment of anemia due to CKD and is not approved by the U.S. Food and Drug Administration (FDA… Article  Vadadustat was noninferior to darbepoetin alfa in terms of the effects on haemoglobin levels and cardiovascular safety outcomes in the two phase III studies comprising the INNO2VATE cardiovascular outcomes program in patients with anaemia secondary to CKD who were dependent on dialysis. INNO2VATE-conversion (NCT02892149) enrolled dialysis patients currently receiving recombinant ESAs who were then converted to either vadadustat or darbepoetin alfa [6]. Coadministration of vadadustat with the OAT1 and OAT3 inhibitor probenecid was associated with increased AUC∞ of vadadustat and its O-glucuronic acid conjugate metabolite. Mitsubishi Tanabe Pharma Corporation. Nephrol Dial Transplant. SKYPE. Akebia Therapeutics (AKBA) Announces Approval of Vadadustat in Japan for Treatment of Anemia Due to CKD. © 2021 Springer Nature Switzerland AG. In this randomized, double-blind trial, patients were randomized to treatment with vadadustat 150 mg (n = 12), 300 mg (n = 12) and 600 mg (n = 13) or placebo (n = 14) once daily for 6 weeks, followed by a 10-week dose adjustment/ maintenance phase (vadadustat dosages were adjusted to achieve a target haemoglobin of 10–12 g/dL; placebo recipients were switched to vadadustat 150, 300 or 600 mg/day). Vadadustat is an investigational therapy and is not approved by the U.S. Food and Drug Administration (FDA). 328]. Clinical trial of vadadustat in patients with anemia secondary to stage 3 or 4 chronic kidney disease. In the global INNO2VATE program in patients with dialysis-dependent CKD, the most common adverse events with vadadustat or darbepoetin were hypertension (16.2% vs 12.9%) and diarrhoea (10.1% vs 9.7%) in INNO2VATE-correction/conversion (n = 181 and 188) and diarrhoea (13.0% vs 10.1%), pneumonia (11.0% vs 9.7%), hypertension (10.6% vs 13.8%) and hyperkalemia (9.0% vs 10.8%) in INNO2VATE- conversion (n = 1777 and 1777) [6]. Corporate News, FDA, Management Comments. Nangaku M, Farag YMK, de Goma E, et al. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond. - 213.219.39.6. Akebia Therapeutics Inc. Akebia Therapeutics announces positive top-line results from global phase 3 program of vadadustat for treatment of anemia due to chronic kidney disease in adult patients on dialysis [media release]. Ltd. About Us; History; Our Team; Company Profile Patients were sequentially assigned to one of three vadadustat starting doses, 300 mg once daily (n = 30), 450 mg once daily (n = 33) or 450 mg thrice weekly (n = 31), all for 16 weeks. Molecular and cellular mechanisms of HIF prolyl hydroxylase inhibitors in clinical trials. Vadadustat increased haemoglobin levels in a predictable and controlled manner and also enhanced iron mobilization in patients with nondialysis-dependent CKD in a double-blind, randomized, placebo-controlled, phase IIb study conducted in the USA (NCT01906489) [21]. Vadadustat (VAFSEO tablets): Japanese prescribing information. Vadadustat was noninferior to darbepoetin alfa in controlling haemoglobin levels in Japanese patients with CKD not dependent on dialysis who were either switched from other erythropoiesis stimulating agents (ESAs) [conversion] or had not received ESAs (correction) in an open label phase III study (NCT03329196) [17]. Akebia Therapeutics announced topline results for PRO2TECT, the second of two Phase III cardiovascular outcomes programs. On June 29, 2020, MTPC obtained approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients. FDA calendar is a useful tool to know PDUFA dates related to FDA Approval and FDA Panel review of New Drug Applications, which are catalysts of Biotech Stocks. 327]. Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the first regulatory approval of vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of J Am Soc Nephrol. Patients were randomized to 6 weeks’ treatment with oral vadadustat 240 (n = 18), 370 (n = 18), 500 (n = 17), or 630 mg (n = 19) once-daily or placebo (n = 19). The LSM average haemoglobin at weeks 20 and 24 (primary endpoint) was 10.61 (95% CI 10.45–10.76 g/dL) in the vadadustat group compared to 10.65 g/dL (95% CI 10.50–10.80 g/dL) in the darbepoetin alfa group, with the 95% confidence interval of both groups within the target range of 10–12 g/dL. No statistically significant mean change in haemoglobin levels from the pre-baseline average to mid-trial (primary endpoint) was observed in any of the three groups [22]. Unchanged drug accounted for 75% of total radioactivity (AUC∞) in plasma after administration of a single oral 650 mg dose of radiolabelled vadadustat to healthy volunteers (n = 6). May 15 (Reuters) - Akebia Therapeutics Inc * Akebia and Vifor Pharma announce exclusive license agreement to provide vadadustat to Fresenius Medical Care in the U.S. upon FDA approval Patients were randomized to receive vadadustat (n = 162) or darbepoetin alfa (n = 161); vadadustat treatment was initiated at 300 mg/day and titrated between 150 mg/day and 600 mg/day to maintain a haemoglobin level of 10–12 g/dL. The primary safety endpoint was the time to first occurrence of MACE (major cardiovascular events; MACE is a composite endpoint of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke); noninferiority was achieved if the upper bound of the 95% confidence interval for the hazard ratio of vadadustat to darbepoetin alfa did not exceed 1.25 (US FDA requirement) or 1.3 (EMA requirement) [6]. 104 (75.4%) and 115 (75.7%) patients in the vadadustat and darbepoetin alfa groups, respectively, had haemoglobin levels within the target range at week 24 [18]. The baseline haemoglobin level in both treatment arms was 10.7 g/dL. 4 Jun 2013. https://akebia.com/. Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support Vadadustat is an investigational therapy and is not approved by the U.S. Food and Drug Administration (FDA). Akebia Therapeutics Inc. Akebia initiates phase 3 PRO2TECT(TM) Program [media release]. The PRV sets Vifor and partner Akebia Therapeutics up to benefit from a fast review at the FDA when they file for approval of chronic kidney disease drug vadadustat. … In a double-blind, randomized 16-week phase II trial in Japanese patients (n = 60) with haemodialysis-dependent CKD (NCT03054350) vadadustat significantly improved the mean haemoglobin change from pretreatment levels to week 6 compared with placebo (primary endpoint) [19]. 0.70, 1.15 and 1.39 g/dL from baseline in the vadadustat 249, 370, 500 and 630 mg/day groups compared to a 0.06 g/dL reduction in the placebo group (all p < 0.05 vs. placebo and baseline). Haase VH, Chertow GM, Block GA, et al. 2016;90(5):1115–22. All authors contributed to the review and are responsible for the article content. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/400315_39990D3F1020_1_01, https://doi.org/10.6084/m9.figshare.12782549, https://doi.org/10.1007/s40265-020-01383-z, A prolyl hydroxylase inhibitor is being developed by Akebia Therapeutics, Inc. for the treatment of anaemia associated with chronic kidney disease, Received its first approval on June 29 2020 in Japan, Approved for use adult patients with anaemia associated with chronic kidney disease, Acetic acids, amides, anti-anaemics, chlorobenzenes, chlorophenols, pyridines, small molecules, Hypoxia-inducible factor-prolyl hydroxylase inhibitor, Pharmacokinetics (day 10; 300 mg once daily), 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid, Vadadustat, darbepoetin alfa, epoetin alfa. -- Vifor Pharma Commits to Exclusive Distribution of Vadadustat to Fresenius Medical Care North America for Use in its Dialysis Facilities and Invests $50 Million in Akebia at a Premium -- -- Additional Funds Support Vadadustat Global Development Program to Data -- ZURICH, SWITZERLAND & CAMBRIDGE, MA, USA - 16 May 2017… Vadadustat will be marketed by MTPC in Japan under the trade name VAFSEO™. 2020;75(4):631. Within Japan, Vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and … US Securities and Exchange Commission. Am J Kidney Dis. 25 Apr 2017. https://akebia.com/. https://doi.org/10.1007/s40265-020-01383-z, DOI: https://doi.org/10.1007/s40265-020-01383-z, Over 10 million scientific documents at your fingertips, Not logged in Accessed 6 Aug 2020. 2017;45(5):380–8. Vadadustat (VAFSEO ®) is a prolyl hydroxylase inhibitor being developed by Akebia Therapeutics, Inc. (Akebia) for the treatment of anaemia associated with chronic kidney disease (CKD). The results of the pre-specified subgroup analyses will be a positive addition to the dataset submitted for review by the FDA and could bolster vadadustat’s FDA approval chances. Fadlan Riix Call Skype. After 16 weeks of treatment, changes in mean absolute haemoglobin from pretreatment levels in the respective vadadustat groups were 0.98, 1.61 and 1.78 g/dL, while that in patients who switched from placebo to vadadustat was 1.42 g/dL. Reticulocytes levels and total iron-binding capacity were significantly increased and serum hepcidin and ferritin levels were significantly decreased in vadadustat recipients compared to the placebo group [21]. A further phase III study (NCT04313153) is evaluating the efficacy and safety of vadadustat once daily and three times weekly for the maintenance treatment of anaemia in haemodialysis patients converting from ESAs. In a double-blind, phase III study conducted in Japan (NCT03439137), vadadustat was as effective as darbepoetin alfa in maintaining haemoglobin levels in Japanese patients with CKD dependent on dialysis who were switched from other ESAs (conversion) [18]. Hypoxia-inducible factor activators in renal anemia: current clinical experience. Pergola PE, Spinowitz BS, Hartman CS, et al. Mean haemoglobin levels increased 0.76. Sawant R, Paulson S, Burke L, et al. 29 Jun 2020. http://www.mt-pharma.co.jp. Randomized, double-blinded, active-controlled (darbepoetin alfa), phase 3 study of vadadustat in CKD patients with anemia on hemodialysis in Japan [abstract no. h/mL; and mean t½ was 5.96, 6.14 and 6.07 h, respectively [5]. Google Scholar. J Am Soc Nephrol. The least square mean (LSM) average haemoglobin level at weeks 20 and 24 (primary endpoint) was 11.66 g/dL (95% CI 11.49–11.84 g/dL) in the vadadustat group compared to 11.93 g/dL (95% CI 11.76–12.10 g/dL) in darbepoetin alfa recipients (LSM difference between groups − 0.26 g/dL (95% CI − 0.50 to − 0.02). The drug was > 99% bound to human plasma protein in vitro [5]. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Sanghani NS, Haase VH. PubMed Central  2019;30:8. 2019;30:825. LSM change in haemoglobin levels from the pretreatment level to week 6 were − 0.28, 0.08, 0.41 g/dL in the vadadustat 150, 300, and 600 mg/day groups compared with − 1.48 g/dL in the placebo group (all p < 0.001 vs. placebo). PubMed  Google Scholar. It is subject to approval of vadadustat by the FDA and inclusion of vadadustat in a bundled reimbursement model, upon which Akebia will receive a $20 million payment from Vifor Pharma. Akebia Therapeutics Inc. Akebia and Vifor Pharma announce exclusive license agreement to provide vadadustat to Fresenius Medical Care in the U.S. upon FDA Approval [media release]. It is in Phase III clinical trials for the treatment of anemia secondary to … Zuk A, Si Z, Loi S, et al. Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for treatment of anemia of chronic kidney disease: two randomized phase 2 trials in Japanese patients. Mean haemoglobin levels between weeks 24 to 36 (primary endpoint) were 10.36 and 10.53 g/dL in vadadustat and darbepoetin alfa recipients, respectively (LSM difference between groups − 0.17 g/dL; 95% CI − 0.23 to − 0.10). SA-OR037]. Chavan AB, Paulson SK, Burke L, et al. PubMed  2019;30:90. The phase II FO2WARD-2 trial (NCT03799627) is an efficacy, safety and pharmacokinetic/pharmacodynamic study evaluating vadadustat for the treatment of anaemia in patients on haemodialysis converting from epoetin alfa. Coadministration with vadadustat increased the Cmax and AUC∞ of the BCRP substrates rosuvastatin, simvastatin, atorvastatin and salazosulfapyridine and the OAT3 substrate furosemide [5], but did not affect the exposure of the OATP1B1 substrate pravastatin or the OAT1 substrate adefovir [13]. Akebia Therapeutics Form 10-K, March 2020. https://akebia.com/. CAS  20 Dec 2016. https://akebia.com/. The lower limit of the 95% confidence interval was above the predefined noninferiority margin of − 0.75 g/dL. Vadadustat is in global Phase 3 development for the treatment of anemia due to CKD and is not approved by the U.S. Food and Drug Administration (FDA) or … Akebia Therapeutics Inc. Akebia and Otsuka Pharmaceutical announce collaboration to develop and commercialize vadadustat in the U.S. [media release]. Vadadustat significantly increased mean haemoglobin levels at week 6 compared with placebo in Japanese patients (n = 51) with non-dialysis-dependent CKD in a 16-week, phase II dose-finding trial (NCT03054337) and by week 16 of treatment, almost all vadadustat recipients achieved target haemoglobin levels [19]. Vadadustat is an investigational therapy and is not approved by the U.S. Food and Drug Administration (FDA). Vous pouvez modifier vos choix à tout moment dans vos paramètres de vie privée. Adv Chronic Kidney Dis. Patients were randomized to receive vadadustat (n = 151) or darbepoetin alfa (n = 153); vadadustat treatment was initiated at 300 mg/day and titrated between 150 mg/day and 600 mg/day to maintain a haemoglobin level of 11–13 g/dL. Nangaku M, Kondo K, Ueta K, et al. After 16 weeks of treatment, changes in mean absolute haemoglobin from pretreatment levels in the respective vadadustat groups were 1.40, 2.44 and 1.64 g/dL, while that in patients who switched from placebo to vadadustat was 1.87 g/dL. Am J Nephrol. Manufacturing and marketing approval of VAFSEO® tablets (HIF-PH inhibitor, vadadustat) for renal anemia in Japan [media release]. BPRL Pvt. 90.9% of patients who had received vadadustat for 16 weeks had a haemoglobin level within the target range of 10–12 g/dL. Sawant R, Paulson S, Burke L, et al. Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 02/24/2021: SUPPL-417: Efficacy-New Indication Effects of vadadustat on hemoglobin concentrations in patients receiving hemodialysis previously treated with erythropoiesis-stimulating agents. Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12782549. Treatment with vadadustat was associated with increased haemoglobin levels and improved biomarkers of iron mobilization and utilization in a double-blind, placebo-controlled phase II trial (NCT01381094) in patients with anaemia secondary to stage 3 or 4 CKD conducted in the USA [20]. Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan. Effect of food intake on the pharmacokinetics of vadadustat following single dose administration [abstract no. 2020;75(4):631. The primary efficacy end point in both studies was the mean change in haemoglobin between baseline and the primary evaluation period (weeks 24–36); non-inferiority was achieved if the lower bound of the 95% confidence interval for the LSM difference between groups in the mean change in haemoglobin levels did not fall below − 0.75 g/dL. Martin ER, Smith MT, Maroni BJ, et al. Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Mean haemoglobin levels between weeks 40–52 (secondary endpoint) were 10.40 and 10.58 g/dL in the vadadustat and darbepoetin alfa groups, respectively (LSM difference between groups − 0.18 g/dL; 95% CI − 0.25 to − 0.12) [6]. Akebia Therapeutics Inc. Akebia and Mitsubishi Tanabe Pharma announce collaboration to develop and commercialize vadadustat in Asia [media release]. Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced the first regulatory approval … Akebia is collaborating with Mitsubishi Tanabe Pharma Corporation on the development and commercializatio … Employee Login . SA-PO229]. PubMed  Google Scholar. The mean haemoglobin level between weeks 24 to 36 (primary efficacy) was 10.36 g/dL in vadadustat-treated patients compared to 10.61 g/dL in the darbepoetin alfa group (LSM difference between groups − 0.31 g/dL; 95% CI − 0.53 to − 0.10). Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in nondialysis-dependent chronic kidney disease. While total iron binding capacity significantly increased and mean absolute ferritin significantly decreased after 16 weeks of vadadustat treatment across all groups, changes in transferrin saturation and hepcidin (apart from in the vadadustat 150 mg/day arm) were not significant [19]. Part of Springer Nature. The ongoing phase III PRO2TECT program in nondialysis-dependent CKD comprises two separate studies; PRO2TECT correction (NCT02648347) in patients with anaemia not currently being treated with recombinant ESAs, and PRO2TECT conversion (NCT02680574) in patients currently receiving recombinant ESAs who were switched to either vadadustat or active control [23]. Evaluation of drug interaction with multiple doses of rabeprazole, a proton pump inhibitor, on the pharmacokinetics of vadadustat [abstract no. Akebia Therapeutics Inc. Akebia Therapeutics reports fourth quarter and full-year 2019 financial results and hosts conference call to discuss recent business highlights [media release]. RIIX WAA SKYPEGA taysiirulquraan Skype Fadliga Quranka In INNO2VATE-correction/conversion, incident dialysis patients with end stage renal disease and limited exposure to recombinant ESAs were randomized to treatment with vadadustat (n = 181) or darbepoetin alfa (n = 188). Nos partenaires et nous-mêmes stockerons et/ou utiliserons des informations concernant votre appareil, par l’intermédiaire de cookies et de technologies similaires, afin d’afficher des annonces et des contenus personnalisés, de mesurer les audiences et les contenus, d’obtenir des informations sur les audiences et à des fins de développement de produit. Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 01/28/2021: SUPPL-36: Labeling-Package Insert, Labeling-Medication Guide Article  Patients with stages 3a to 5 non-dialysis-dependent CKD were randomized to 20 week’s treatment with vadadustat starting at 450 mg once daily and titrated to effect, or placebo. J Am Soc Nephrol. According to the Japanese prescribing information, adverse events occurring in ≥ 1% but < 5% of patients treated with vadadustat in Japanese trials were hypertension, diarrhoea and nausea [5]. Coadministration of vadadustat with the proton pump inhibitor rabeprazole was not associated with clinically relevant changes in vadadustat exposure [14]. PubMed  15 May 2017. https://akebia.com/. TH-OR024]. The O-glucuronic acid conjugate metabolite of the drug is a substrate of OAT3 and has an inhibitory effect on OAT3. Both trials in the INNO2VATE programme were multinational, multicentre studies comparing treatment with vadadustat (starting at 300 mg once daily, then titrated in increments of 150 mg within the range of 150–600 mg/day) to darbepoetin alfa (at the recommended dose). J Am Soc Nephrol.
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