FDA Approves Xromi Oral Solution for Use in Pediatric Patients with Sickle Cell Anemia
Xromi has been approved by the FDA as an oral solution formulation of hydroxyurea indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises.
- Sickle cell anemia is caused by an abnormal version of hemoglobin called hemoglobin S, which leads to sickle-shaped red blood cells that can form painful clumps inside the blood vessels. These painful episodes are called sickle cell crises and are one of the most common and distressing symptoms of sickle cell disease.
- Hydroxyurea has been shown to reduce the frequency of painful episodes associated with sickle cell disease. It is thought to work by increasing levels of hemoglobin F (also called fetal hemoglobin because it is present in newborn babies) to make the red blood cells bigger, rounder, more flexible, and less likely to turn into a sickle shape.
- Xromi, manufactured by Nova Laboratories, Ltd., is supplied as a strawberry flavored oral solution containing 100 mg/mL hydroxyurea. The Xromi package contains two oral dosing syringes.
Source: FDA
