AbbVie Receives Orphan Drug Status for Venetoclax

The European Medicines Agency has granted orphan drug designation to AbbVie’s experimental acute myeloid leukemia treatment venetoclax.

The designation makes the oral B-cell lymphoma-2 inhibitor eligible for EU-level grants and member state programs, as well as assistance with protocol design.

The FDA granted venetoclax both breakthrough therapy designation and orphan drug designation for treatment of chronic lymphocytic leukemia, and the EMA granted it orphan drug status for treatment of CLL.

AbbVie has partnered with Genentech and Roche to develop venetoclax.