- cafead Aug 23, 2021 at 11:22: AM
via The U.S. Food and Drug Administration (FDA) has a busy schedule for the end of August and beginning of September. Let’s take a look.
Cara and Vifor’s Korsuva for Pruritus in Hemodialysis Patients
Cara Therapeutics and Vifor Pharma have a target action date of August 23, 2021, for their New Drug Application (NDA) for Korsuva (difelikafalin) for moderate-to-severe pruritus in hemodialysis patients. It is under Priority Review. Pruritus is severe itching. The NDA is built on positive data from two pivotal Phase III trials, KALM-1, run in the U.S., and KALM-2, which was international, as well as data from another 32 clinical studies.
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Cara and Vifor’s Korsuva for Pruritus in Hemodialysis Patients
Cara Therapeutics and Vifor Pharma have a target action date of August 23, 2021, for their New Drug Application (NDA) for Korsuva (difelikafalin) for moderate-to-severe pruritus in hemodialysis patients. It is under Priority Review. Pruritus is severe itching. The NDA is built on positive data from two pivotal Phase III trials, KALM-1, run in the U.S., and KALM-2, which was international, as well as data from another 32 clinical studies.
article source