Sanofi (SNY) Rilzabrutinib Receives US Breakthrough Therapy and Japanese Orphan Drug Designations

The U.S. Food and Drug Administration granted breakthrough therapy designation to Sanofi (SNY)’s rilzabrutinib for Waldenström macroglobulinemia, a rare form of non-Hodgkin lymphoma. Separately, the Japanese Ministry of Health, Labour and Welfare designated rilzabrutinib as an orphan drug for the same indication, underscoring its potential in treating rare diseases. These designations are expected to expedite development and regulatory review timelines, potentially improving patient access and supporting SNY’s growth in oncology pipelines.