A rare but severe stem cell transplant complication that often becomes fatal now has its first FDA-approved treatment, a therapy developed by biotechnology company Omeros.
The Christmas Eve regulatory decision covers the treatment of adults and children age 2 and older who develop hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). This complication stems from the formation of blood clots in small blood vessels in vital organs, damaging them. The main treatment options have been supportive measures.
Omeros develops drugs that address the complement system, a part of the immune system. The…