Cara’s Phase III Success In CKD-Pruritus Puts NDA Filing In Sight
Second Phase III study expected later this year, but Cara wants to discuss the possibility of accelerated filing with the US FDA. It also has an oral formulation in Phase II for less severe CKD patients.
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The kappa opioid receptor agonist is not listed as a scheduled substance and labeling meets expectations. Cara and partner Vifor plan to launch the product in early 2022.
I.V. Korsuva now has an August FDA action date, which partner Vifor would commercialize in the ESRD dialysis setting while Cara works toward a broad anti-pruritus label for its oral tablet formulation.
Public Company Edition: Two months before the deadline for the company's sNDA, the US FDA has not indicated it will hold an advisory committee meeting for the triglyceride-lowering drug. Also, Seattle Genetics raises $575m, Atara and Ra bring in $150m each and Cara completes $145.5m offering.