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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.
education & researchRandomized Feasibility Trial to Improve Hydroxyurea Adherence in Youth Ages 10–18 Years Through Community Health W...Introduction: The main therapeutic int...
education & researchDevelopment of a Hydroxyurea Decision Aid for Parents of Children With Sickle Cell AnemiaNational evidence-based guidelines recom...
videos & visualsSickle Cell Disease, Hydroxyurea: What You Should Knowhttps://www.onescdvoice.com/wp-content/u...
news & eventsSCA Therapy Hydroxyurea Doesn’t Boost Malaria Risk in Sub-Saharan Africa, Study FindsHydroxyurea, a treatment recommended for...
videos & visualsA Conversation on Hydroxyurea: Insights and Information for the Sickle Cell Communityhttps://www.youtube.com/watch?v=Y6fmJn-5...
news & eventsEffort set to help sickle cell patients manage medsVanderbilt University Medical Center is ...
videos & visualsHow to Talk to Your Child About Hydroxyureahttps://www.youtube.com/watch?v=_apTt2j0...
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