Sanofi Secures US FDA Orphan Drug Status For SAR446523, A GPRC5D Monoclonal Antibody Under Development For Treating Multiple Myeloma

The U.S. FDA has given orphan drug designation to Sanofi’s experimental treatment SAR446523, a special type of antibody (called an ADCC-enhanced IgG1 monoclonal antibody) that targets GPRC5D, a protein commonly found on cancerous plasma cells in multiple myeloma patients. This designation supports the potential use of SAR446523 in treating people with relapsed or hard-to-treat multiple myeloma, a rare blood cancer.

Orphan drug designation is given to treatments for rare diseases that affect fewer than 200,000 people in the U.S., helping speed up development and provide benefits like market exclusivity if approved. SAR446523 is still under investigation and has not yet been proven safe or effective by any regulatory body.

Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi, stated, “The orphan drug designation is a significant milestone in our ongoing efforts to develop innovative treatments in multiple myeloma. This underscores our commitment to multiple myeloma, a disease for which we have acquired strong expertise with the development of another widely used and approved immunotherapy treatment.”