CARA

Korsuva IV (CR845 IV)

Pruritus CKD-HD

NDA Submission

Exp Date

H2 2020

Amp Volatility Score

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.


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)


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).



Updated by HC

CARA, Korsuva IV (CR845 IV), Pruritus CKD-HD, NDA

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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