Emmaus Life Sciences receives FDA approval for Endari label changes

Emmaus Life Sciences (EMMA) has received Food and Drug Administration approval for changes to the labelling of Endari to reflect additional prescribing information derived from post-marketing pharmacokinetic study data submitted by Emmaus. The additional information provides a more comprehensive characterization of Endari, including confirmation of dosing by body weight, no unwanted accumulation through twice daily dosing, and the ability to administer Endari with or without food. Endari is approved in the U.S. and elsewhere to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.