Topline data were announced from a phase 3 trial evaluating luspatercept-aamt plus Janus kinase 2 inhibitor (JAKi) therapy in adults with myelofibrosis-associated anemia receiving red blood cell (RBC) ...

In 2022, the FDA had made the decision to ban the products because the applications lacked sufficient evidence to show they met a public health standard.

The approval was supported by data from the randomized, double-blind, placebo-controlled, event-driven phase 3 FINEARTS-HF study.