Cara Therapeutics Inc. (NASDAQ:CARA) and Vifor Fresenius Medical care Renal Pharma (VFMCRP) have announced that the EMA will review their MAA for difelikefalin injection for treating pruritus related to chronic kidney disease (CKD) in hemodialysis patients. The EU medicines agency will review the MAA application as per the centralized marketing authorization procedure.
EMA to give MAA decision for difelikefalin use in the US in Q2 2022
The companies will support the EMA filing with positive clinical data from pivotal Phase II trials KALM-1 and KALM-2 and additional supportive data from 32 clinical studies. Once approved, difelikefalin will receive marketing authorization in all EU member states and Liechtenstein, Norway, and Iceland. The EMA will give the EU MAA decision on the injection in Q2 2022.
Stefan Schulze, Vifor Pharma Group CEO, said following the US FDA’s approval of their priority review for difelikefalin NDA at the start of last month. The EMA approval will be a massive step in bringing treatment for kidney patients undergoing hemodialysis. Further, he added that in partnership with Cara, they are focused on availing the innovative therapy in Europe once approved for patients with CDK –related pruritus, an underdiagnosed and undertreated condition.
Difelikefalin the first-in-class pruritus therapy
Cara Therapeutics CEO and President Derek Chalmers said that the acceptance of difelikefalin EU regulatory application is a massive milestone towards the goal of bringing a first-in-class therapy to a large number of hemodialysis patients with chronic intractable pruritus globally. He said that they are looking forward to working closely with Vifor Pharma on the EMA review process ahead of commercial launch across the EU once approved.
Chronic kidney disease-associated pruritus is an intractable systemic condition occurring with high intensity and frequency in CKD patients undergoing dialysis. Similarly, pruritus has been observed in patients with stage III-V CKD that are not in dialysis. Most dialysis patients report pruritus, and 30-40% experience moderate-to-severe pruritus. Moderate-to-severe pruritus results in reduced quality of life and can lead to symptoms that impact life quality.