FDA Approves ENDARI® for Sickle Cell Disease

The FDA on July 7, 2017 approved ENDARI® (L-Glutamine oral powder) for oral administration to reduce the acute complications of Sickle Cell disease, in adult and pediatric patients 5 years and older. There is a higher L-glutamine utilization in Sickle Cell Anemia resulting in its depletion and thereby contributing to oxidative stress. This oxidative stress is an important contributing factor to hemoglobin polymerization, with polymer formation occurring only in the deoxy state. ENDARI® is the first treatment approved for patients with Sickle Cell disease in almost 20 years.