FDA accepts Empliciti BLA for priority review

The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for Empliciti (elotuzumab), from US pharma majors Bristol-Myers Squibb (NYSE: BMY) and AbbVie (NYSE: ABBV).

Empliciti is an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies. Empliciti was previously granted Breakthrough Therapy Designation (The Pharma Letter May 19, 2014), which according to the FDA, is intended to expedite the development and review of drugs for serious or life-threatening conditions. The European Medicines Agency also recently validated for review the Marketing Authorization Application for Empliciti, granting it accelerated assessment.

Bristol-Myers has proposed the name Empliciti which, if approved by health authorities, will serve as the brand name for elotuzumab. Bristol-Myers and AbbVie are co-developing elotuzumab, with the former solely responsible for commercial activities.