FDANews
FDAnews Drug Daily Bulletin

FDA Approves First New Sickle Cell Drug in 20 Years

July 11, 2017

The FDA on Friday approved Endari, the first new drug in nearly 20 years to treat sickle cell anemia complications.

The L-glutamine oral powder, sponsored by Emmaus Medical, was approved for adults and children over 5 years old to reduce severe complications associated with the blood disorder. Previously, the only available treatment was hydroxyurea, approved by the FDA in 1998.

Though glutamine is currently sold as a nutritional supplement and a medical food, Emmaus’ L-glutamine will be produced and sold as a prescription drug.

View today's stories