An­oth­er PhI­II win in hand, Cara aims straight for pri­or­i­ty re­view of 'break­through' pru­ri­tus drug

Cara Ther­a­peu­tics has cleared the fi­nal hur­dle be­tween its lead pro­gram and an NDA fil­ing, hit­ting the pri­ma­ry end­point on its sec­ond Phase III tri­al for an in­jectable to treat pru­ri­tus among he­modial­y­sis pa­tients.

KALM-2 had es­sen­tial­ly the same de­sign as KALM-1 ex­cept that it had a broad­er pa­tient pop­u­la­tion, in­volv­ing Eu­ro­pean and Asia Pa­cif­ic sites in ad­di­tion to US ones. As such, while Cara works to­ward a US ap­pli­ca­tion in the sec­ond half of 2020, the da­ta pack­age should al­so help its part­ners at Vi­for Fre­se­nius make a case at the EMA by the end of the year.

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