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Biomedtracker Diabetic Nephropathy/Diabetic Kidney Disease KOL Interview

May 13, 2016

Biomedtracker interviewed a nephrologist based in the US Midwest to determine his views on the drugs in development for diabetic nephropathy/diabetic kidney disease.

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Highlights
  • Efficacy on outcomes cannot readily be predicted from differences in the urine albumin-creatinine ratio (UACR) biomarker.
  • Cardiovascular benefits are more important to many physicians than renal ones.
  • Expects Invokana (JNJ), finerenone (Bayer), and atrasentan (ABBV) will all do fine from an efficacy standpoint, but atrasentan will be the least tolerable.
  • If Invokana confirms the renal and cardiovascular benefits of Jardiance (Boehringer, LLY), there will be tremendous uptake of the SGLT2 inhibitors, especially since they also benefit glucose and blood pressure control.
    • By the time the pivotal diabetic nephropathy trials of the late-stage drugs are finished, primary care physicians will be much more familiar with Invokana and so will use it ahead of finerenone and atrasentan.
    • Jardiance may be able to be approved for diabetic nephropathy based on the renal findings in its EMPA-REG CV outcomes trial, but after the results are confirmed by Invokana.
  • Expects finerenone will perform second in the market, with very positive cardiovascular outcomes and renal outcomes that are positive, but not stellar.
    • Hyperkalemia should be less of an issue than for current mineralocorticoid antagonists.
  • Believes atrasentan will turn out to be more of a designer drug for select patients.
    • While its pivotal trial is screening for responders and excluding patients that are likely to have issues with fluid retention from the drug, busy physicians may not want to deal with screening or patient discontinuation.
  • Notes levels of blood pressure differences versus control in pivotal trials that could lead to approvability issues with the FDA, since they could be responsible for the renal benefits.
  • Phase 2 immunologically based compounds are likely to have problems attracting investment.
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For our disclosures, please read the Biomedtracker Research Standards.
Indications Covered: Diabetic Nephropathy

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