Google
Trusted Resources: News & Events
Latest announcements and gatherings
FDA Approves Hydroxyurea Tablets for Pediatric Patients With Sickle Cell Anemia
The US Food and Drug Administration (FDA) has approved hydroxyurea tablets (Siklos, ADDMEDICA) for the treatment of sickle cell anemia in pediatric patients aged 2 years and older.
Previously, the hydroxyurea tablets were granted priority review and orphan drug designations from the FDA. Sickle cell anemia, by recent estimates, impacts roughly 100,000 Americans.
The approval was granted based on efficacy and safety data from the Escort-HU study, which included 1047 patients with sickle cell anemia (495 children). The mean hydroxycarbamide levels in the pediatric patients at initiation was 18 mg/kg and 17.3 mg/kg.
+myBinderRelated Content
-
The Family Perspectivehttp://www.sicklecelltransplantconsortiu...
-
Siklos (hydroxyurea) now available through ProCare Pharmacy Care’s Siklos At Home programMedunik USA announced today that...
-
Sickle cell disease and albuminuria: recent advances in our understanding of sickle cell nephropathyAlbuminuria is considered to be a releva...
-
A Conversation on Hydroxyurea: Insights and Information for the Sickle Cell Communityhttps://www.youtube.com/watch?v=Y6fmJn-5...
-
Improved clinical outcomes in adults with sickle cell disease and diabetes treated with metforminComplications of sickle cell disease (SC...
-
Pediatric sickle cell study stopped early due to positive resultsA national sickle cell disease study inv...
-
Early clinical trial data show gene therapy reversing sickle cell anemiaAfter over a decade of preclin...
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.