FDA gives Cara and Vifor consolation prize with Korsuva nodding in pruritus in chronic kidney disease patients
Patients with chronic kidney disease on hemodialysis who suffer from the incessant itching of pruritus finally have some relief.
The FDA has approved Vifor Pharma’s Cara Therapeutics and Korsuva for this disease. The drug, which is injected three times a week, offers significant improvements in safety and efficacy over the current variety of antihistamine treatments used to combat pruritus.
The moderate to severe level of disease, for which the drug is approved, affects approximately 40% of the more than 500,000 CKD patients on hemodialysis.
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“Because there are no approved therapies to treat moderate to severe pruritus for this patented population, Korsuva will help fill a significant unmet medical need,” said Eric Vandal, vice president of business operations at Cara. , during a conference call.
Recognizing this, the FDA has awarded Korsuva a breakthrough therapy designation and priority review leading to Monday’s green light.
Cara of Stamford, Connecticut developed the drug and added business partner Vifor from Switzerland. The companies plan to launch Korsuva in the first quarter of 2022 and hope to secure reimbursement and access to patients through Medicare and Medicaid in the first half of 2022. Cara said she has yet to determine the drug’s price.
The nod was based on two Phase 3 studies involving 1,300 dialysis patients with CKD with moderate to severe pruritus, which showed that 40% and 37% of Korsuva recipients achieved a four point improvement over baseline on a measure of their most severe itching compared to 21% and 26% for those who received the placebo.
The drug (difelikefalin) is an opioid agonist that targets the kappa opioid receptor in the peripheral nervous system, as opposed to morphine and other opioid pain relievers, which work by activating the mu opioid receptor in the central nervous system. By avoiding receptors in the brain and spinal cord, the drug is believed to not leave patients prone to nausea, respiratory depression, and the potential for abuse of traditional opioids.
Korsuva contains warnings regarding dizziness, drowsiness, changes in mental status, and gait disturbances. The treatment can cause impairment when driving a car or using machines. None of these side effects were evident in more than 7% of patients who received Korsuva in the trials.
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The FDA’s go-ahead is sort of a consolation prize for Korsuva, which has struggled to show its effectiveness in a Phase 2 trial for atopic dermatitis. Cara also suffered setbacks in her attempt to develop an oral version of the drug.
On Monday, however, the company didn’t seem to be put off by the stumbling blocks. CEO Derek Chalmers believes the approval may help Cara rediscover the promise she once envisioned for Kosuva.
“We’re going to have this income benefit that is going to fund this other part of the pipeline,” said Chalmers, who then mentioned “the oral development of Kosuva, which expands the application of Kosuva beyond hemodialysis and then to other patient populations “.