FDA clears first new sickle cell treatment in 20 years

Emmaus Life Sciences said last week that the FDA approved its L-glutamine oral powder, Endari, as a therapy to lessen the complications of sickle cell disease in patients ages 5 and older. The drug’s approval was supported by data from a Phase III trial evaluating Endari compared to a placebo in 230 adults and children with sickle cell disease. The data showed that Endari cut the frequency of sickle cell crises by one-fourth and hospitalizations by 33%, according to Emmaus. Get the full story at our sister site, Drug Delivery Business News. The post FDA clears first new sickle cell treatment in 20 years appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance emmauslifesciences Source Type: news