The European Medicines Agency (EMA) has validated the marketing authorization application for Empliciti (elotuzumab), an investigational monoclonal antibody being developed by Bristol-Myers Squibb and AbbVie, for treating multiple myeloma. The application was granted accelerated assessment by the EMA's Committee for Medicinal Products for Human Use.

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

Empliciti is a signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody for treating multiple myeloma as a combination therapy in adult patients who have received one or more prior therapies. SLAMF7 is a cell-surface glycoprotein expressed on myeloma cells and natural killer cells, but is not detected on normal solid tissues or on hematopoietic stem cells.

Empliciti previously obtained orphan drug designation in the European Union (EU). An orphan medicinal product must be intended for the treatment, prevention or diagnosis of a disease that is life threatening and chronically debilitating; the prevalence in the EU must not be more than five in 10,000. The medicine must be of significant benefit to those affected by the condition. If maintained, orphan drug designation allows sponsors to access a number of incentives, including protocol assistance and receive market exclusivity for a ten-year period following approval.

Source: Bristol-Myers Squibb