The US Food and Drug Administration (FDA) has declined to approve Unicycive Therapeutics’ drug, oxylanthanum carbonate, for treating elevated phosphate levels in chronic kidney disease patients on dialysis. The decision was made due to deficiencies at a third-party manufacturing facility.
Impact on Patients
High phosphate levels are common in patients with chronic kidney disease and are linked to higher risks of hospitalization and death. The current treatment landscape for hyperphosphatemia in chronic kidney disease includes Sanofi’s Renvela and Akebia’s Auryxia.
The FDA’s decision does not raise concerns about the drug’s safety or effectiveness, and no additional clinical data is required. Unicycive Therapeutics’ shares were down over 36% in premarket trading following the announcement.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
