Key Takeaways
- Omeros’ second attempt for FDA approval of narsoplimab has been delayed by three months, now set for Dec. 26.
- The antibody is intended to treat TA-TMA, a severe complication associated with stem cell transplants.
- Despite the delays, Omeros reported significant survival benefits from recent data analysis supporting narsoplimab’s efficacy.
FDA Approval Timeline Extended
Omeros faces another setback in its bid for FDA approval of its transplant drug, narsoplimab, now delayed by three months. Initially, the FDA was set to reassess the anti-MASP-2 antibody by September 25. However, the agency has pushed the decision date to December 26, citing the need for additional information from Omeros. In its communication, the FDA noted that “assuming no major deficiencies are identified during its review, labeling discussions are planned to begin no later than October 2025,” according to Omeros’ second-quarter earnings report.
The need for further analysis stemmed from a prior rejection in 2021, where the FDA expressed concerns over the treatment effect estimates based on Omeros’ initial submission. This prompted the biotech firm to appeal the decision and submit new analysis regarding the drug’s performance. Most recently, Omeros presented data indicating that narsoplimab improved overall survival by 68% compared to untreated patients. The study involved a phase 2 trial with 28 patients suffering from TA-TMA, concluding in 2020.
Involving over 100 patients from an external control registry without the treatment, the FDA has called for a comparison of survival rates, a move that Omeros has aligned with in its latest submission. Despite the ongoing challenges, Omeros remains optimistic. Gregory Demopulos, M.D., CEO of Omeros, stated, “Working closely with FDA, we continue preparing for the anticipated approval and subsequent launch of narsoplimab in TA-TMA, an indication with an increasingly large and recognized unmet need for which there is no approved treatment.”
Meanwhile, as the company focuses its resources on narsoplimab, it announced a temporary pause on clinical developments for two other projects—zaltenibart, a MASP-3 inhibitor, and OMS1029, a long-acting MASP-2 inhibitor. Zaltenibart is already prepared for a phase 3 trial in paroxysmal nocturnal hemoglobinuria, while OMS1029 is being geared for a phase 2 study with a yet-to-be-announced indication.
Despite the delays, Demopulos mentioned that “substantial industry interest across our assets” is leading to ongoing discussions for potential partnerships, suggesting a positive outlook with various milestones expected to materialize in 2025 and 2026. Omeros’ commitment to advancing its products indicates its intent to navigate the complex approval landscape and drive innovations in treatments for critical health conditions.
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