Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics announced on April 28, 2022 that the European Commission (EC) has granted marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritis associated with chronic kidney disease (CKD) in adult hemodialysis patients.
The treatment was approved by FDA in the United States in August 2021 for the same indication under the name Korsuva. The EC approval allows the treatment to be used in all member states of the European Union, as well as Iceland, Liechtenstein, and Norway. According to the company, Kapruvia is the first approved therapy in Europe for the treatment of pruritis associated with CKD in hemodialysis patients. The first launches in Europe are expected in the second half of 2022.
“We are very excited about the European Commission’s approval of Kapruvia, marking an important milestone on our journey to advance and fundamentally change the treatment paradigm for people living with the severe burden of pruritus associated with chronic kidney disease,” said Dr. Klaus Henning Jensen, chief medical officer of Vifor Pharma, in a press release. “We look forward to bringing this first-in-class therapy to patients in Europe, with launch in first markets expected in the second half of 2022.”
“The European Commission’s approval of Kapruvia provides a much-needed therapy to hemodialysis patients in Europe who suffer from pruritus,” said Dr. Joana Goncalves, Chief Medical Officer of Cara Therapeutics. “We are excited to bring an innovative drug to physicians to help change the way pruritus is managed. We continue to work with our commercial partner VFMCRP, to fill a significant unmet medical need among CKD patients with pruritus in both the U.S. and Europe.”
Source: Cara Therapeutics
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.