CARA

Korsuva IV (CR845 IV)

Pruritus CKD-HD

Stage (next event)

Expected Date

NDA Submission

Q4 2020

Catalyst Info & Data Links

TITLE: Korsuva IV (CR845 IV) in Pruritus CKD-HD - NDA Submission


WHAT IS THE CATALYST EVENT?

  • NDA Filing


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?


PRIOR DATA/EVENTS


PRESS RELEASES

POSTERS

  • 2017: (Kidney Week) Randomized, Placebo-Controlled Study on the Efficacy of CR845 inReducing Chronic Kidney Disease-associated Pruritus in Hemodialysis Patients


PRESENTATIONS



PUBLICATIONS

  • 2020: A phase 3 trial of difelikefalin in hemodialysis patients with pruritus. New England Journal of Medicine, 382(3), 222-232.


Mechanism of Action

MECHANISM OF ACTION / RATIONALE

  • Difelikefalin (CR845) is a peripherally restricted, selective kappa opioid receptor agonist that exerts antipruritic effects by means of activation of kappa opioid receptors on peripheral neurons and immune cells. The hydrophilic small-peptide structure restricts passive diffusion across membranes, thereby limiting access to kappa opioid receptors in the central nervous system (Fishbane et al., 2020).



COMPETITORS

MARKET

  • >500K patients undergoing dialysis in the US

  • ~60% of end-stage renal disease (ESRD) patients have pruritus

  • ~40% have moderate to severe pruritus

  • Source - May 2020 Corporate Presentation (slide 7)


Updated by MV

Prior Data (click to view full image)

Chart

Trial Design / Revenue (click to view full image)

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