AnaMar Announces US and EU Orphan Drug Designation for AM1476 for Treating Systemic Sclerosis
AM1476 offers a unique dual-action approach to treat both skin and lung manifestations of systemic sclerosis.
- AM1476 offers a unique dual-action approach to treat both skin and lung manifestations of systemic sclerosis.
- Systemic sclerosis is a chronic, progressive, autoimmune disease characterized by inflammation and fibrosis, i.e.
- AnaMar's Chief Executive Officer, Dr. Ulf Ljungberg, said: “We are delighted with the FDA’s and EMA’s decisions to grant orphan drug designation to AM1476 for SSc.
- Orphan drug designation provides certain benefits, including the potential for extensive marketing exclusivity following regulatory approval, reduction in regulatory fees and, in the case of EU, a centralized approval process.