NEWS
RedHill's Opaganib Granted Orphan Drug Designation by the FDA for Childhood Cancer, Neuroblastoma
RedHill Biopharma (Nasdaq: RDHL) has announced that the FDA has granted orphan-drug designation to opaganib for the treatment of neuroblastoma, a rare childhood cancer.
This designation provides seven years of marketing exclusivity if approved and may offer additional benefits such as accelerated development and review times, potential grant funding, and tax credits.
Neuroblastoma accounts for up to 10% of childhood cancer cases and 15% of pediatric cancer-related deaths in the U.S. The neuroblastoma market is expected to reach nearly $1.5 billion before the mid-2030s.
This is the second orphan drug designation for opaganib in oncology, following its designation for cholangiocarcinoma. Opaganib is being developed for multiple indications, including COVID-19, Ebola, and acute respiratory distress syndrome.
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