FDA Approves Updated Label for Endari

Emmaus Life Sciences has announced revised prescribing information for Endari® to better inform healthcare professionals and sickle cell disease patients. Based on approval from the FDA, the updated label includes a statement that the clinical benefit of Endari® was observed irrespective of hydroxyurea usage and a new step-by-step instruction for use section at the end of the prescribing information.

"This label update provides important information to help clinicians make informed decisions on the use of Endari," said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer 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® was approved by the FDA in July 2017 for the treatment of sickle cell disease in adult and pediatric patients five years of age and older and sales began in 2018.