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ADDMEDICA receives FDA-approval for orphan drug Siklos®, first and sole hydroxyurea-based treatment for paediatric patients with sickle cell anaemia


 

ADDMEDICA has announced that the US Food and Drug Administration (FDA) has approved Siklos® (hydroxyurea tablets) in paediatric patients, two years of age and older, suffering from sickle cell anaemia.

Approval was obtained under a priority review and orphan drug designation.

Particularly suitable for paediatric populations, Siklos® offers dosing options to facilitate adjustment based on the patient’s weight to obtain the best efficacy/tolerance ratio for each child throughout the growth years.

FDA-approval of Siklos® was granted based on efficacy and safety data collected in a cohort study, Escort-HU, which included several hundred child and adult patients treated with Siklos® in Europe.

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