FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves Pediatric Sickle Cell Drug

Jan. 2, 2018

Siklos and Addmedica’s hydroxyurea for treating pediatric sickle cell anemia patients received FDA approval.

The drug aims to reduce the need for blood transfusions in pediatric sickle cell patients two years of age and older.

The FDA based the approval on a 405-patient study involving patients from 2 to 18 years old. Researchers found the percentage of patients with at least one illness-related episode or blood transfusion decreased after 12 months of treatment.

View today's stories