BioLineRx has announced that the U.S. Food & Drug Administration (FDA) has granted an Orphan Drug Designation to BL-8040 as a therapeutic for the treatment of acute myeloid leukemia (AML).
Orphan Drug Designation is granted to therapeutics intended to treat rare diseases that affect not more than 200,000 people in the United States.
Orphan Drug Designation entitles the sponsor to a seven-year market exclusivity period, clinical protocol assistance with the FDA, as well as federal grants and tax credits.
"We are very pleased to have received Orphan Drug Designation for BL-8040, which will facilitate the development process of one of our key clinical stage assets," stated Dr. Kinneret Savitsky, Chief Executive Officer of BioLineRx.
"Currently, AML treatment options, especially in patients with a relapse of the disease, are extremely limited. BL-8040 has the potential to be a significant addition to the drug arsenal for this disease, especially when considering its promising pre-clinical results, unique biological mechanism and ability to synergize with other drugs already approved for this disease. Therefore, we are eagerly looking forward to the partial results of BL-8040's Phase 2 study expected towards the end of 2013," concluded Dr. Savitsky.