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FDA Takes Caution Opinion on Rebrozyl for the Treatment of Nontransfusion Dependent (NTD) Beta Thalassemia

 Last Update: 2022-04-24
 Source: Internet
 Author: User

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Thalassemia (thalassemia) is a hereditary chronic hemolytic disease caused by reduced or complete absence of globin chain synthesis due to mutation or deletion of the globin gene
.
According to clinical manifestations, thalassemia is divided into major thalassemia and non-transfusion-dependent thalassemia (NTDT)

Infect

NTDT patients are asymptomatic at birth, and usually develop after 2 to 3 years of age, which gradually worsens with age, mainly manifesting as mild to moderate chronic anemia.
Most of the patients with HGB are 70-100 g/L.
Oxidative drugs can cause anemia to worsen due to hemolysis
.
Most patients have no typical thalassemia appearance, normal growth and development or slightly delayed, and hepatosplenomegaly may be present

Bristol-Myers Squibb announced Friday that the FDA has extended its review of an application seeking expanded approval of Rebrozyl (luspatercept) for the treatment of adults with non-transfusion-dependent (NTD) beta thalassemia by three months
.
FDA believes that additional time is required to fully review the submission

FDA

Results presented at the European Haematology Association (EHA) Congress showed that approximately 77% of patients treated with Rebrozyl increased Hb by ≥1.
0 g/dL from baseline over a consecutive 12-week interval from Weeks 13 to 24, reaching primary endpoint
.
In addition, 52.

1% of subjects in the Rebrozyl group had a mean increase in Hb of ≥ 1.

During consecutive 12-week intervals between Weeks 13 and 24, approximately 77% of Rebrozyl-treated patients had a ≥1.

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