
FDA grants orphan drug designation to relapsed or refractory multiple myeloma candidate
Ella Day | August 6, 2025 | News story | Medical Communications, Research and Development | Oncology, Sanofi, US Food and Drug Administration, myeloma
The US Food and Drug Administration (FDA) has granted orphan drug designation to SAR446523, Sanofi’s investigational monoclonal antibody developed for the potential treatment of relapsed or refractory multiple myeloma (MM). The antibody targets GPRC5D, a receptor found on malignant plasma cells in individuals with MM.
SAR446523 is an IgG1-based monoclonal antibody designed to engage the immune system through antibody-dependent cellular cytotoxicity. The candidate is currently being evaluated in a phase 1 clinical trial as a subcutaneous treatment in patients who have previously received therapy for MM.
MM is a rare cancer of plasma cells. Although it is considered incurable, existing treatments have extended survival in many cases. However, most patients eventually relapse, and treatment resistance is common. This reinforces the urgent need for candidates such as SAR446523.
The orphan drug designation is intended for investigational therapies that treat conditions affecting fewer than 200,000 people in the US. The designation provides certain regulatory incentives, including eligibility for market exclusivity if the product is approved.
The safety and efficacy of SAR446523 have not been established, nor has it been reviewed or approved by any regulatory authority.
Ella Day
6/8/25
Related Content

Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …

European Commission approves HIV prevention injection
The European Commission (EC) has granted marketing authorisation for Gilead Science’s Yeytuo (lenacapavir), the first …

FDA approves Wegovy for treatment of MASH in adults with liver fibrosis
The US Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) as …






