June 30 (Reuters) – Uniycive Therapeutics said on Tuesday the U.S. Food and Drug Administration had declined to approve its drug to treat elevated phosphate levels in chronic kidney disease patients on dialysis, citing deficiencies at a third-party manufacturing facility.
Shares of the company were down over 36% in premarket trading.
This marks yet another setback for the company, which was attempting to bring the drug, oxylanthanum carbonate, a convenient alternative for patients suffering from a complication known as hyperphosphatemia in chronic kidney disease.
The regulator in its so-called complete response letter said there were no concerns about the drug’s safety or effectiveness and did not request additional clinical data.
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.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shinjini Ganguli)
