CHMP positive for extension of indication of Reblozyl (luspatercept-aamt)for i. transfusion-dependent anaemia due to low and intermediate-risk myelodysplastic syndromes. ii. anaemia with transfusion dependent beta thalassaemia.- BMS
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Reblozyl.
The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma .
The CHMP adopted an extension to an existing indication as follows: Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy .
For information, the full indications for Reblozyl will be as follows: i. Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). ii. Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non-transfusion dependent beta thalassaemia.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins