FDA Grants Orphan Drug Status to MDS Biologic

BI 836858 is an anti-CD33 monoclonal antibody designed for improved antibody-dependent cell-mediated cytotoxicity
BI 836858 is an anti-CD33 monoclonal antibody designed for improved antibody-dependent cell-mediated cytotoxicity

Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to BI 836858 for the treatment of myelodysplastic syndromes (MDS).

The Company is currently evaluating BI 836858 in a randomized, multicenter, open-label, dose-escalation Phase 1/2 clinical trial in patients with MDS. In addition, a first-of-its-kind collaborative trial program, Beat AML Master Trial, is ongoing for BI 836858, in collaboration with the Leukemia & Lymphoma Society (LLS), for acute myeloid leukemia (AML). 

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BI 836858 is an anti-CD33 monoclonal antibody designed for improved antibody-dependent cell-mediated cytotoxicity (ADCC).

For more information call (800) 542-6257 or visit Boehringer-ingelheim.com.