Reblozyl
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News
CLINICAL NEWS | FDA Approves Luspatercept for First-line Treatment of Anemia in Lower-Risk MDS
The approval was based on interim results from the pivotal phase 3 COMMANDS trial (ClinicalTrials.gov Identifier: NCT03682536) that evaluated the efficacy and safety of luspatercept in 356 patients with anemia due to international…
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Scientific News
TOP STORY | EU Approves Luspatercept for Anemia in Patients with Non–Transfusion-Dependent β-Thalassaemia
The approval was based on findings from the phase 2 BEYOND trial, which demonstrated that 77.1% of patients treated with luspatercept (n = 74/96) experienced a mean haemoglobin (Hb) increase…
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News
FDA Grants Priority Review to Luspatercept-aamt for Anemia in Adults With NTD β-Thalassaemia
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2022. In addition, the European Medicines Agency (EMA) has validated the Type II variation…
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News
Coming Up This Thursday: Discussion On Access To Innovative Therapies – The Reblozyl Case
After receiving numerous questions from patients regarding the innovative treatment for β-thalassaemia Reblozyl (luspatercept), approved for use in the US, Europe, and Canada, TIF proceeds to organise an interactive, online…
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News
Health Canada Approves REBLOZYL® For Adult Patients with β-Thalassaemia
Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc. announced today that Health Canada has approved REBLOZYL® (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia…
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TIF News
TIF.ACCESS: A Global TIF Initiative for the Promotion of the Availability & Accessibility of Innovative Therapies
The swift scientific progress made in the field of thalassaemia research has gained momentum with the market authorisations of both the Zynteglo Gene Therapy by the European Medicines Agency (EMA)…
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News
European Commission Approves Reblozyl for the Treatment of Transfusion-dependent β-Thalassaemia
Bristol Myers Squibb (BMS) & Acceleron Pharma announced today that the European Commission approved Reblozyl (luspatercept) for the treatment of Transfusion-Dependent β-#Thalassaemia (TDT) in adult patients. Reblozyl has the potential to…
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Webinars
eThalED COURSE: Access to New Therapies – The Case of Reblozyl by Dr. Antonio Piga
The 1st webinar for Medical Specialists organised in the context of TIF’s eThalED online course is here. Dr Antonio Piga, Professor of Paediatrics & Dean of the Medicine School at…
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News
Accessibility & Affordability of Novel Therapies for Thalassaemia: The Patients’ Perspective
9 patients with thalassaemia, members of TIF’s Patient Advocacy Group for Thalassaemia and Sickle Cell Disease (T-PAG), are discussing with the Thalassaemia International Federation the accessibility and affordability of the…
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News
Reblozyl (luspatercept-aamt) Receives Positive CHMP Opinion for the Treatment of Adults with β-Thalassaemia
On 30 April 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product REBLOZYL, intended for the treatment of adults…
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