By Padmanabhan Ananthan
June 30 (Reuters) – Unicycive Therapeutics said on Tuesday the U.S. drug regulator has 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 fell more than 44% in early trading.
This marks a second setback for the company, which was seeking approval for its drug, oxylanthanum carbonate (OLC), designed to treat a condition known as hyperphosphatemia in patients with chronic kidney disease.
The condition causes a dangerous buildup of phosphorus in the blood when failing kidneys can no longer filter it out.
The regulator in its so-called complete response letter (CRL) said there were no concerns about the drug’s safety or effectiveness and did not request additional clinical data.
Piper Sandler’s Yasmeen Rahimi called the CRL a “minor setback” and continues to see a high likelihood of OLC’s approval, citing the absence of new FDA concerns about the drug’s efficacy or safety.
This follows a CRL from last June that also cited manufacturing deficiencies at a third-party vendor.
Unicycive said the latest CRL cites the same issues as last time and argued that the agency did not inspect the third-party manufacturing site during the review of the resubmitted application.
Chief Executive Shalabh Gupta said the company remains confident in the drug and “optimistic that there will be a successful inspection of the third-party manufacturing vendor and that we will be able to expeditiously resubmit the NDA.”
The current treatment landscape for hyperphosphatemia in chronic kidney disease includes Sanofi’s Renvela and Akebia’s Auryxia.
However, unlike Renvela and Auryxia, which can involve a high daily pill burden, Unicycive said that its drug was designed to lower both the number and size of pills needed to control phosphate levels.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shinjini Ganguli)
