Acceleron expects BLA for luspatercept to be submitted in April

Acceleron (XLRN) said it and Celgene (CELG) plan to submit a Biologics License Application to the FDA for luspatercept in patients with anemia related lower-risk myelodysplastic syndromes and beta-thalassemia in April 2019. It added, Acceleron and Celgene remain on track to submit a Marketing Authorization Application to the European Medicines Agency for luspatercept in patients with anemia related to lower-risk MDS and beta-thalassemia in the first half of 2019…The ongoing Phase 2 trial of luspatercept in patients with MF has completed target enrollment, with preliminary results expected in the second half of 2019…Enrollment is ongoing in the COMMANDS Phase 3 trial in patients with first-line lower-risk MDS and the BEYOND Phase 2 trial in patients with non-transfusion-dependent beta-thalassemia, with preliminary results expected from the BEYOND trial in 2020.”
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