The Food and Drug Administration rejected filings from Unicycive Therapeutics and Swedish Orphan Biovitrum (Sobi) due to contract manufacturing deficiencies, according to an announcement on June 30. The agency issued a second rejection to Unicycive for its oxylanthanum carbonate (OLC) treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis, citing ongoing issues at a third-party manufacturing plant.
Unicycive had previously received a rejection from the FDA one year ago for the same product because of problems at the same vendor. After initially preparing to work with a different manufacturer, Unicycive ultimately stayed with its original service provider based on perceived progress toward compliance. However, the FDA's latest complete response letter cited unresolved deficiencies at that facility. The agency has not yet inspected the vendor as part of this review cycle, according to Unicycive.
Unicycive said it refiled its application believing that the vendor was making progress addressing previous concerns and demonstrating readiness for inspection. During a meeting in September, the FDA discussed the manufacturer but did not express new concerns about its progress, according to statements from Unicycive. Despite this, investor concerns persisted after comments made by Vishnukant Bhutada of Shilpa Pharma indicated validation batches would be completed later than expected. Guggenheim Securities analysts noted last month that while these comments may have worried investors—causing a 12.6% drop in share price—Unicycive maintained there was likely a misunderstanding regarding which facility supported initial launch versus later market expansion.
Following news of the latest complete response letter, Unicycive CEO Shalabh Gupta said he is “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.” Guggenheim analysts stated Tuesday, “Management says that the inspection has now been ‘assigned’ and should take place in the coming weeks,” adding that if successful, resubmission could follow quickly with potential approval later this year.
Days before Unicycive’s announcement, Sobi revealed it also received an FDA rejection for approval of nanoencapsulated sirolimus plus pegadricase (NASP) for adults with uncontrolled gout due to similar manufacturing issues. The FDA requested additional data relating mainly to control strategies for NASP’s biological component and deficiencies at another contract manufacturing site. Sobi plans meetings with regulators and partners to address these points before refiling.
