The Fly

Bristol-Myers announces CHMP opinion recommending approval for Reblozyl

Bristol Myers announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has recommended approval of Reblozyl as a treatment for adult patients with anemia associated with non-transfusion-dependent, or NTD, beta thalassemia. The recommendation will now be reviewed by the European Commission, or EC, which has the authority to approve medicines for use in the European Union, or EU. Upon approval, this would represent the third authorized indication for Reblozyl in the EU. The CHMP adopted the opinion based on results from the pivotal Phase 2 BEYOND study, evaluating the efficacy and safety of Reblozyl versus placebo in 145 adults with NTD beta thalassemia. Patients were eligible to receive best supportive care, including red blood cell transfusions, iron-chelating agents, use of antibiotic, antiviral, and antifungal therapy, and/or nutritional support, as needed.

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