US biopharmaceutical company Emmaus Life Sciences Inc (OTCQB:EMMA) announced on Thursday that it has received US Food and Drug Administration (FDA) approval for changes to the labelling of Endari to reflect additional prescribing information derived from post-marketing pharmacokinetic study data submitted by Emmaus.

The company says that the additional information provides a more comprehensive characterisation 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 United States and elsewhere to reduce the acute complications of sickle cell disease in adult and paediatric patients five years of age and older.