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Omeros Corporation recently announced that the U.
After receiving HSCT, patients usually have a complicated clinical course, usually severe
Omeros still has confidence in the efficacy and safety data of narsoplimab in HSCT-TMA
Omeros plans to request a Class A meeting with the FDA as soon as possible to discuss CRL and determine the fastest way to approve narsoplimab for HSCT-TMA
Efficacy data of narsoplimab
The clinical part included in the narsoplimab BLA is based on the results of a key phase 3 clinical trial previously reported in HSCT-TMA
Primary endpoint: The CRR of the study population and the lower limit of the 95% confidence interval (95% CI) significantly exceeded the curative effect threshold (15%).
Secondary endpoints: (1) The 100-day survival rate (defined as the survival rate from the date of HSCT-TMA diagnosis) exceeded expert expectations (less than 20%): 68% of all patients receiving treatment, According to the protocol, 83% of patients who received narsoplimab treatment for at least 4 weeks, and 93% of patients who responded to narsoplimab treatment
Safety: The most common adverse reactions in the trial were diarrhea, nausea, vomiting, hypokalemia, neutropenia, and fever.
Mechanism of action of narsoplimab
HSCT-TMA is a serious and often fatal complication of hematopoietic stem cell transplantation (HSCT).
Narsoplimab is a fully human IgG4 monoclonal antibody that targets mannose-binding lectin-associated serine protease 2 (MASP-2) and is developed for the treatment of HSCT-TMA
Previously, narsoplimab was granted the breakthrough drug qualification for the treatment of high-risk HSCT-TMA patients, the prevention of complement-mediated thrombotic microangiopathies (TMA) and the orphan drug qualification for the treatment of HSCT-TMA in the United States, and was granted the treatment of hematopoietic stem cell transplantation in the EU (HSCT) orphan drug eligibility
Note: The original text has been deleted
Original source: Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA
