The Food and Drug Administration (FDA) has approved updated labeling for Endari® (L-glutamine; Emmaus Medical) to better inform healthcare professionals and sickle cell disease patients.
Endari, an amino acid, was approved by the FDA in July 2017 to reduce the acute complications of sickle cell disease in adult and pediatric patients aged 5 years and older. L-glutamine is believed to improve the NAD redox potential in sickle red blood cells by increasing the availability of reduced glutathione.
The Clinical Studies section has been updated to include a statement that the clinical benefit of Endari was observed irrespective of hydroxyurea use. The clinical benefit was based on efficacy data from a phase 3 trial which evaluated Endari in 230 patients aged 5 to 58 years with sickle cell anemia or sickle β0-thalassemia.
Additionally, the updated labeling includes a new step-by-step instruction for use section.
“This label update provides important information to help clinicians make informed decisions on the use of Endari,” said Yutaka Niihara, MD, MPH, Chairman and CEO of Emmaus. “We are particularly pleased with the FDA’s acknowledgement that the clinical benefit of Endari is not affected by hydroxyurea use. That acknowledgement reinforces and supports the use of Endari as a monotherapy or in combination with hydroxyurea as important treatment options for patients with sickle cell disease.”
Endari is available as packets containing 5g of L-glutamine powder in 60-count cartons.
For more information visit endarirx.com.
- FDA approves updated label for Endari®. [press release]. Torrance, CA: Emmaus Life Sciences, Inc; November 3, 2020.
- Endari [package insert]. Torrance, CA: Emmaus Medical, Inc; 2020.