Bristol Myers Squibb today announced positive top-line results from the ongoing, ex-US, Phase 2 registrational study evaluating Reblozyl (luspatercept-aamt) versus placebo for anemia in adults with Alpha (α)-Thalassemia.

The non‑transfusion‑dependent (NTD) and transfusion‑dependent (TD) cohorts of the study met their respective primary endpoints, with Reblozyl demonstrating a statistically significant and clinically meaningful increase in hemoglobin levels in NTD patients with α‑thalassemia, and a statistically significant and clinically meaningful decrease in red blood cell (RBC) transfusion burden in TD patients with α‑thalassemia. The study also met all key secondary endpoints. Safety findings were consistent with the known profile of Reblozyl in thalassemia.

“These positive data further support the potential of Reblozyl for patients around the world,” said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development, Bristol Myers Squibb. “This is the first and only registrational Phase 2 trial specifically designed to address the needs of patients, especially in China, with alpha-Thalassemia, a lifelong disease with limited treatment options and the potential for serious long‑term complications.”

The data will be presented at an upcoming medical congress and will be discussed with the Center for Drug Evaluation in China.