To Evaluate Long- Term Safety and Efficacy of Luspatercept

Launched by FONDAZIONE PER LA RICERCA SULLE ANEMIE ED EMOGLOBINOPATIE IN ITALIA · Mar 10, 2025

Keywords

ClinConnect Summary

Luspatercept represents the first and only erythroid maturation agent (EMA) approved by the European Commission (EC) and the Food and Drug Administration (FDA) capable of enhancing advanced erythrocyte maturation. The efficacy of luspatercept was demonstrated in the phase III clinical trial called "BELIEVE." With market authorization, the drug is used in less selected patients with potentially more complex medical histories than those enrolled in the registration study. In addition, it is now also possible to prescribe the drug in patients with blood consumption at baseline between 20 and 2...

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Subjects who received at least one dose of luspatercept after its introduction in the clinical practice
• Exclusion Criteria:
• • Subjects who received luspatercept after participating in the "compassionate" use program
• • Subjects unwilling to sign informed consent