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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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.
Cara Therapeutics will discuss its options with regulators after positive top-line data from adaptive Phase II/III trial of its Korsuva drug in patients undergoing abdominal surgeries met its prime endpoint and sent the biotech's stock higher.
A Vifor Fresenius joint venture will market Korsuva for CKD-associated pruritis to Fresenius dialysis centers in Europe, and also will do a co-promotion with Cara in the US that may provide a significant head start for the drug.