Omeros drug for stem cell transplant complication to get US FDA priority review

Omeros Corp.'s biologics license application for narsoplimab to treat a life-threatening complication of stem cell transplants has been accepted by the U.S. Food and Drug Administration and granted priority review.

Narsoplimab treats hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA. The condition occurs in 40% of the 25,000 to 30,000 patients that undergo stem cell transplants in the U.S. and Europe each year, according to a Jan. 19 news release.

The U.S. regulator is set to decide on the application by July 17 and does not plan to hold an advisory committee meeting to discuss narsoplimab. Priority review is granted to therapies that could provide a significant improvement over existing treatments for serious conditions.

Omeros' application is supported by results from a late-stage study in which 61% of patients with HSCT-TMA who received at least a single dose of narsoplimab had no signs of the disease after the treatment period. On average, the patients survived for 274 days.

Narsoplimab was previously granted orphan drug and breakthrough therapy designations by the FDA. The therapy won the EU's backing for approval in October 2019.