RedHill Biopharma Announces Positive FDA Meeting Regarding Opaganib for Acute Nuclear Radiation Syndrome
"We are pleased to align with the FDA on the Animal Rule development pathway for opaganib for ARS.
- "We are pleased to align with the FDA on the Animal Rule development pathway for opaganib for ARS.
- "Given the promising data already generated with opaganib for ARS, we are set to continue collaborating with a range of U.S. agencies in addition to discussions with other governments."
- In the relevant study models, opaganib was associated with protection of normal tissue, including gastrointestinal tissue, from radiation damage due to ionizing radiation exposure or cancer radiotherapy.
- Opaganib, an oral, small molecule pill with a five-year shelf-life, is easy to administer and distribute, supporting, if approved, potential central government stockpiling for use in mass casualty nuclear radiation incidents.