Calliditas Plans To File For Complete FDA Approval For Rare Kidney Disease Drug After Positive Phase 3 Data

  • Calliditas Therapeutics AB CALT announced topline results from the Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (TARPEYO/Kinpeygo (budesonide) delayed-release capsules) versus placebo in patients with primary IgA nephropathy (IgAN).
  • The trial studied Nefecon on primary IgA nephropathy (IgAN) patients who were also on RAS inhibitor therapy. 
  • The drug demonstrated a "highly statistically significant benefit" over the placebo in two years, with nine months of treatment studying the primary endpoint of estimated glomerular filtration rate (eGFR), a measure of the level of kidney function. 
  • Also Read: Analyst Sits On Fence While Initiating Calliditas Citing 'Near-Term Opportunity But Longer-Term Questions'
  • Supportive 2-year total slope analyses were statistically significant and clinically meaningful, reflecting a sustained treatment benefit.
  • The eGFR was, on average, 5.05 mL higher with Tarpeyo compared to the placebo (p<0.0001) over two years.
  • Urine protein-to-creatinine ratio reductions observed were durable, reflecting a long-lasting treatment effect during the 15-month follow-up period off treatment.
  • Tarpeyo received FDA accelerated approval in December 2021 and conditional marketing authorization from the European Commission in July 2022.
  • Based on the data, Calliditas plans to file for full approval from the FDA and support a filing for full approval with the EC and UK's MHRA during 2023.
  • Price Action: CALT shares are up 38.4% at $23.29 on the last check Monday.
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