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FDA Approves Xromi

FDA Approves Xromi (hydroxyurea) Oral Solution for Use in Pediatric Patients with Sickle Cell Anemia

April 4, 2024 -- The U.S. Food and Drug Administration (FDA) has approved Xromi, 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.

Hydroxyurea was first approved in 1967 in an oral capsule formulation as a cancer treatment, and has been used by doctors to treat sickle cell anemia since the 1980s. It was approved by the FDA for treating adults with sickle cell anemia in 1998, and children in 2017.

Xromi is supplied as a strawberry flavored oral solution containing 100 mg/mL hydroxyurea. The Xromi package contains two dosing oral dosing syringes (a red oral dosing syringe graduated to 3 mL and a white oral dosing syringe graduated to 12 mL) for accurate measurement of the prescribed dose.

Xromi is manufactured by Nova Laboratories, Ltd. for Rare Disease Therapeutics, Inc.

Posted: April 2024

Xromi (hydroxyurea) FDA Approval History

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