French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Wednesday that the US Food and Drug Administration has granted orphan drug designation to SAR446523 for the potential treatment of relapsed or refractory multiple myeloma.

SAR446523 is an IgG1-based monoclonal antibody designed to enhance Antibody-Dependent Cellular Cytotoxicity. It targets GPRC5D, a receptor highly expressed in multiple myeloma cells with limited presence in healthy tissues.

The orphan designation applies to therapies intended for rare diseases affecting fewer than 200,000 patients in the United States.

Sanofi highlighted the designation as a key milestone in its multiple myeloma research and development efforts.

According to the company, SAR446523 builds on its established expertise in the therapeutic area, which includes a previously approved immunotherapy.

The investigational treatment remains under clinical evaluation, and its safety and efficacy have not yet been assessed by any regulatory authority.