VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the Marketing Authorization Application for difelikefalin

Regulatory News:

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Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients. The EMA will review the application under the centralized marketing authorization procedure.

The EMA filing is supported by positive clinical data from the two pivotal phase-III trials KALM-1 and KALM-2, as well as supportive data from an additional 32 clinical studies. If approved, difelikefalin would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. EMA’s decision on the EU MAA is expected Q2-2022.

“Following the US FDA’s acceptance and priority review for the New Drug Application for difelikefalin at the beginning of March 2021, this is another major step forward on our mission to help kidney patients around the world lead better, healthier lives,” commented Stefan Schulze, CEO of Vifor Pharma Group. “Together with our partner Cara Therapeutics, we remain focused on making this innovative therapy available in Europe, if approved, for patients with chronic kidney disease-associated pruritus, a condition that has been historically underdiagnosed and undertreated.”

“The acceptance of the EU regulatory application for difelikefalin marks another major milestone towards our goal of bringing this first-in-class therapeutic to the significant number of hemodialysis patients worldwide with chronic intractable pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We look forward to working closely with our partner, Vifor Pharma, through the EMA review process and in preparation for commercial launch across European territories, if approved.”

About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).