Google
Trusted Resources: News & Events
Latest announcements and gatherings
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.
+myBinderRelated Content
-
Hydroxyurea and Sickle Cell Disease: A HRSA EMBRACE Projecthttps://www.youtube.com/watch?v=AyMP3P9E...
-
Effects of Hydroxyurea (HU) on Neurocognitive Performance in Children With Sickle Cell Disease: A Prospective TrialSickle cell anemia is associated with pr...
-
Off-label prescription of hydroxycarbamide (hydroxyurea, HU) for severe anemia: preliminary results from European no...HU is licensed in Europe in the preventi...
-
Sickle Cell Disease Research Shows Progress in Preventing Related Complications and DeathStudies aim to limit pain crises, preven...
-
Pediatric sickle cell study stopped early due to positive resultsA national sickle cell disease study inv...
-
Hydroxyurea improves lung function in children with sickle cell diseaseFor the first time, researchers were abl...
-
Sickle Cell Disease, Hydroxyurea: What You Should Knowhttps://www.onescdvoice.com/wp-content/u...
To improve your experience on this site, we use cookies. This includes cookies essential for the basic functioning of our website, cookies for analytics purposes, and cookies enabling us to personalize site content. By clicking on 'Accept' or any content on this site, you agree that cookies can be placed. You may adjust your browser's cookie settings to suit your preferences. More Information
The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.
Powered by
Support for this site is provided by
This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.