- Israel-based RedHill Biopharma ( NASDAQ: RDHL ) announced Wednesday that the European Commission granted Orphan Drug Designation to RHB-204 as a treatment for nontuberculous mycobacteria (NTM) disease.
- The American depository shares of RDHL added ~5% in reaction.
- The decision follows a positive opinion issued by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).
- Pulmonary NTM lung disease is a chronic lung disease that affects an estimated 28,000 people in the EU.
- The advantages of European orphan drug designation include eligibility for ten years of post-launch market exclusivity.
- RDHL is in talks with partners to advance RHB-204 in multiple regions. A Phase 3 trial is currently underway in the U.S. to evaluate the candidate in adults with pulmonary NTM disease caused by its leading causative agent, Mycobacterium avium complex (MAC).
For further details see:
RedHill wins EU’s orphan drug status to RHB-204 for rare lung disease