BRIEF—Cara Therapeutics files NDA for Korsuva

US biopharma company Cara Therapeutics has submitted a New Drug Application (NDA) to the US Food and Drug Administration for Korsuva Injection (difelikefalin) for the treatment of moderate-to-severe pruritus in hemodialysis patients.

Korsuva Injection received Breakthrough Therapy designation from the FDA for this indication.

Cara has requested Priority Review for the NDA which, if granted, could result in a six-month review process.

The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

The drug is partnered for the US market with Swiss drugmaker Vifor Pharma under a deal worth a potential $540 million to Cara.

Some analysts have forecast that Korsuva could potentially bring in over $500 million sales at peak.