Bristol Myers: EU approval extended for Reblozyl
The laboratory states that the EU approval applies to all EU member states.
'With this approval [...] more patients in the EU will be able to detach themselves from transfusions for longer periods of time compared to currently available options', said Monica Shaw. M.D., Senior Vice President and Head of European Markets at BMS.
The approval is based on a pivotal Phase 3 study.
BMS recalls that Reblozyl is already approved in the U.S. and Japan for the first-line treatment of anemia associated with low-risk MDS.
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