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# Boehringer Myelodysplastic Syndromes Therapy Given Orphan Status
- URL: https://www.fdaweb.com/boehringer-myelodysplastic-syndromes-therapy-given-orphan-status/
- Published: 2017-03-09T12:00:00.000Z
- Updated: 2026-09-14T22:10:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138168

FDA has granted Boehringer Ingelheim an orphan drug designation for its anti-CD33 monoclonal antibody BI 836858 for treating myelodysplastic syndromes (MDS). “Preclinical studies with our anti-CD33 monoclonal antibody have shown promising therapeutic potential in myelodysplastic syndromes, a rare group of bone marrow disorders,” the company says. A Phase 1-2 multi-center, open-label, dose escalation and randomized trial ([NCT02240706](https://clinicaltrials.gov/ct2/show/NCT02240706?ref=fdaweb.com)) evaluating BI 836858 in patients with MDS is ongoing.

  
BI 836858 is a monoclonal antibody that targets a protein called CD33, which is expressed on the surface of certain cancerous cells. It has been engineered for improved antibody-dependent cell-mediated cytotoxicity, an immune reaction where a target cell or microbe is coated with antibodies and killed by certain types of white blood cells, according to the company.