Cara Placing Korsuva Hopes On Oral Formulation, Broad Pruritus Label
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.
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Cara Therapeutics and licensee Vifor Pharma have released positive topline data from the KALM-2 study in chronic kidney disease patients with moderate-to-severe pruritus undergoing hemodialysis, using a first-in-class selective kappa opioid receptor agonist which does not enter the CNS.
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.
Lilly plans a head-to-head study of donanemab versus Biogen’s Aduhelm to see which clears amyloid plaque better and has begun a rolling BLA toward accelerated approval of the Alzheimer’s drug.