Cara Therapeutics submits NDA for injectable pruritus treatment
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Cara Therapeutics has submitted a new drug application to the FDA for its injectable form of difelikefalin, a medication designed to treat moderate-to-severe pruritus in patients on hemodialysis.
The company received FDA breakthrough therapy designation for Korsuva injection and has requested the application be granted priority review, according to a press release issued by Cara Therapeutics.
Submission of the NDA follows positive results of several clinical studies, as well as two pivotal phase 3 trials. Healio Nephrology previously reported on phase 3 of the KALM-2 study, which demonstrated that 54% of patients who received the injection experienced a reduction of itch intensity compared with 42% of those who received placebo.
“The NDA submission for Korsuva injection marks a significant milestone for Cara and for hemodialysis patients who suffer from intractable pruritus,” Derek Chalmers, PhD, DSc, president and CEO of Cara Therapeutics, said in the release. “We look forward to working with the FDA through the review process and, along with our commercial partner, Vifor Pharma, remain focused on preparation for the U.S. launch of Korsuva injection, if approved.”
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