RedHill Biopharma Ltd. (Nasdaq: RDHL) („RedHill“ or the „Company“), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to opaganib for treatment of neuroblastoma, a type of childhood cancer that develops from immature nerve cells and accounts for 15% of all pediatric cancer-related deaths.
Orphan Drug designation provides for a seven-year marketing exclusivity period should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times, potential grant funding and possible tax credits.
Neuroblastoma usually affects children aged five or younger but does also occur in older children. In the United States, approximately 650 new cases are diagnosed each year, accounting for around 10% of all childhood cancer cases. Treatment typically involves a combination of surgery, chemotherapy, radiation therapy, and sometimes targeted therapy or immunotherapy. New options are urgently needed.
The neuroblastoma market is expected to reach almost $1.5 billion before the middle of the next decade.
