Sanofi (SNY) said Monday that Japan's Ministry of Health, Labour and Welfare has granted orphan drug designation to its experimental medicine rilzabrutinib for the treatment of IgG4-related disease.
The company said orphan drug status in Japan is given to treatments targeting rare diseases or conditions with significant unmet medical needs.
Sanofi said rilzabrutinib was evaluated in a phase 2 trial, where 52 weeks of treatment reduced disease flare-ups and other key disease markers, while lowering patients' need for glucocorticoid therapy.