FDA Grants Orphan Drug Designation to Boehringer Ingelheim’s Myelodysplastic Syndrome Drug

Boehringer Ingelheim has been granted orphan drug designation by the FDA for its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes.

The drug candidate, BI 836858, is a monoclonal antibody that targets a protein called CD33, which is expressed on the surface of certain cancerous cells. BI 836858 has been engineered for improved antibody-dependent cell-mediated cytotoxicity.

Myelodysplastic syndromes are bone marrow disorders in which the bone marrow is characterized by cell abnormalities and ineffective blood cell production.

BI 836858 previously received orphan drug designation for the treatment of patients with AML.