China-based Hong Kong WinHealth Pharma Group has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for review for difelikefalin. WinHealth holds exclusive development and commercialization rights to the Category 5.1 drug in China, following a licensing deal secured with Vifor Fresenius Medical Care Renal Pharma in January 2023.
Difelikefalin: A κ-Opioid Receptor Agonist for Itching Relief
Difelikefalin is a κ-opioid receptor (KOR) agonist that works by binding to receptors to inhibit the production of itching sensations. This drug stands out compared to most opioids, as it is not classified as a controlled substance and does not induce adverse reactions typically associated with opioid drugs, such as respiratory depression.
Global Approvals for Difelikefalin in Chronic Kidney Disease Patients
Difelikefalin has already received approval in the US, European Union, Japan, United Kingdom, and several other regions for the treatment of moderate to severe itching in adult patients with chronic kidney disease who are undergoing hemodialysis. The drug’s potential approval in China would further expand access to this therapeutic option for patients in the country.-Fineline Info & Tech
