Rather than accepting a loss when the FDA rejected its stem-cell-associated blood clot med, Omeros took the road less traveled with an appeal, arguing that there's enough data to support the approval of narsoplimab. Now, that effort has likely been stalled until after August.
After meeting with the agency’s Office of New Drugs (OND) in July, Omeros said Wednesday that the agency needs to collect additional information, which will delay the appeal ruling. Omeros says the 30-day countdown to a decision on the appeal won’t start until “the additional information is collected and any required follow-up is conducted by the deciding official.” The move all but guarantees that a final ruling on whether narsoplimab should be approved or not won’t be made in August, as was anticipated by Omeros.
The update is the latest in the ongoing saga between Omeros and the FDA regarding the stem cell transplant-associated blood clot med narsoplimab, which was rejected in October 2021. According to the company at the time, the FDA wasn’t able to determine a clear treatment effect for the drug and required additional information. No issues regarding safety or the chemistry, manufacturing and controls were raised as part of the rejection.
Omeros has since disputed the rejection, preparing a formal appeal and contending that there’s enough data to support the use of narsoplimab. The appeal was officially submitted in June and Omeros says it met with the OND in July to press the case. Had additional information not been needed, a ruling would’ve been required within 30 days of the meeting taking place. The company previously said a ruling was anticipated in August.
Omeros first applied for approval of narsoplimab in November 2020 based on data from a 28-person, open-label, single-arm trial. Such trials tend to be easier to conduct than placebo-controlled trials because they require fewer patients. Narsoplimab previously received orphan drug and breakthrough therapy designations from the FDA and is also being developed to treat IgA nephropathy, blood clots in the kidneys, lupus nephritis and other renal diseases.
In a second-quarter earnings report earlier this month, CEO Gregory Demopulos, M.D., said Omeros remains “confident that approval of narsoplimab in TA-TMA is warranted.” The company will just have to wait a bit longer to find out whether the OND agrees.