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# FDA Approves Celgene’s Reblozyl for Some Anemic Adults
- URL: https://www.fdaweb.com/fda-approves-celgenes-reblozyl-for-some-anemic-adults/
- Published: 2019-11-08T12:00:00.000Z
- Updated: 2026-09-14T15:52:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145463

FDA has approved Celgene’s Reblozyl (luspatercept-aamt), the first therapy to treat anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. An agency [notice](https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-treat-patients-rare-blood-disorder?ref=fdaweb.com) says that beta thalassemia (Cooley’s anemia) is an inherited blood disorder that reduces the production of hemoglobin. In people with beta thalassemia, low hemoglobin levels can lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue, and more serious complications, FDA says.

The notice says approval of Reblozyl was based on results of a clinical trial of 330 patients with beta thalassemia who required red blood cell transfusions. Some 21% of the patients who received Reblozyl achieved at least a 33% reduction in transfusions, compared to 4.5% of patients receiving a placebo.

Common side effects associated with Reblozyl were headache, bone pain, arthralgia, fatigue, cough, abdominal pain, diarrhea, and dizziness.

FDA granted the Reblozyl application a fast track designation and an orphan drug designation.