Sanofi (SNY) said Monday the US Food and Drug Administration granted Breakthrough Therapy designation to rilzabrutinib, an oral Bruton's tyrosine kinase inhibitor, for the treatment of warm autoimmune hemolytic anemia.

The Japanese Ministry of Health, Labour and Welfare also awarded the drug orphan designation for the same rare autoimmune condition, the drugmaker said.

These regulatory statuses are based on safety and efficacy results from the phase 2b and phase 3 Lumina clinical trial, Sanofi said.

The drug obtained an orphan drug designation in other regions for IgG4 disease and sickle cell disease, it said.