FDA Gives Priority Review to BMS, AbbVie DrugBy
The US Food and Drug Administration has accepted for priority review the biologics license application of Bristol-Myers Squibb and AbbVi for Empliciti (elotuzumab), an investigational drug for treating multiple myeloma as a combination therapy in patients who have received one or more prior therapies.
Empliciti was previously granted breakthrough therapy designation by the FDA. The European Medicines Agency (EMA) also recently validated for review the marketing authorization application for Empliciti, granting it accelerated assessment.
Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health authorities, will serve as the brand name for elotuzumab. Elotuzumab is an investigational immunostimulatory antibody targeted against SLAMF7 (signaling lymphocyte activation molecule), a cell-surface glycoprotein that is expressed on myeloma cells and natural diller cells, but is not detected on normal solid tissues or on hematopoietic stem cells.
Source: Bristol-Myers Squibb