Metabolic acidosis is a common condition in chronic kidney disease (CKD) that increases in prevalence and severity as kidney function worsens. Recently, metabolic acidosis has been identified as a key risk factor for the progression of CKD. Metabolic acidosis is measured and defined as a serum bicarbonate level <22 mEq/L and is typically treated with oral sodium bicarbonate. Adding excess sodium to patients with certain co-morbidities, such as CHF, uncontrolled hypertension, and other cardiovascular conditions, can cause fluid overload and raise hypertension even further.
Tricida is developing veverimer (TRC101) as a potential novel treatment for metabolic acidosis. A New Drug Application was filed in September 2019 and expects to launch the drug in 2020 assuming FDA approval.
Market Dynamix™: Metabolic Acidosis (US) is a syndicated report that includes patient level data from large-scale, independent chart audits and survey feedback from 102 US nephrologists. Market size, distribution of serum bicarbonate levels by CKD stage, comparative unmet needs in the dialysis and non-dialysis settings, current treatment approaches and limitations, an attribute importance assessment for new treatments for metabolic acidosis, and physician reaction to a product profile for veverimer, a phase 3 agent in development for metabolic acidosis by Tricida, Inc. is included in the report. Year over year shifts in familiarity with and reaction to veverimer as well as changes in disease awareness included.
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- What is the comparative level of unmet need for new products to treat metabolic acidosis?
- What percent of patients in CKD, 3, 4, 5 (ND), PD and HD have metabolic acidosis?
- How is metabolic acidosis currently treated in the non-dialysis setting and how satisfied are nephrologists with current options?
- How familiar are physicians with veverimer and what is their reaction to the product profile? How is veverimer perceived relative to efficacy in lowering serum bicarbonate, the potential to delay the progression of CKD, tolerability, safety, anticipated cost, and patient convenience?
- Considering products in the renal pipeline – including HIF-PH inhibitors (roxadustat, vadadustat, daprodustat), Bayer’s finerenone, Reata’s bardoxolone, Ardelyx’s tenapanor and others – which one is the most desired and why?
- What are the perceived advantages and disadvantages of veverimer and in what percentage of patients do nephrologists anticipate using the product assuming it is FDA approved?
- Primary market research conducted with 102 US nephrologists in September 2019
- A prior wave was conducted in September 2018
- Serum bicarbonate levels for over 1,000 patients by CKD Stage 3-5 non-dialysis, from RealWorld Dynamix: Chronic Kidney Disease 2018. Chart audit conducted in November-December 2018.
- Serum bicarbonate levels for over 1,000 hemodialysis and peritoneal dialysis patients, from RealWorld Dynamix: Dialysis 2019. Chart audit conducted in April-May 2019.