WEDNESDAY, Nov. 13, 2019 — Reblozyl (luspatercept-aamt) has been approved to treat anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions, the U.S. Food and Drug Administration announced Friday.
Reblozyl is the first approved therapy that will help to reduce the number of blood transfusions for this patient population, Richard Pazdur, M.D., director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research, said in a statement. Reblozyl is administered through a subcutaneous injection with a recommended starting dose of 1 mg/kg once every three weeks.
Approval of Reblozyl was based on clinical data from 336 patients with beta thalassemia who required RBC transfusions; 112 patients received placebo. Researchers found that 21 and 4.5 percent of patients who received Reblozyl and placebo, respectively, achieved at least a 33 percent reduction in transfusions, meaning they needed fewer transfusions over 12 consecutive weeks.
Commonly reported side effects of Reblozyl include headache, bone pain, arthralgia, fatigue, cough, abdominal pain, diarrhea, and dizziness. Patients taking Reblozyl may also experience hypertension and have an increased risk for thrombosis/thromboembolism. Health care professionals are advised to monitor patients’ blood pressure and to monitor them for signs and symptoms of thromboembolic events during treatment.
Approval was granted to Celegene Corporation.
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Posted: November 2019