The FDA granted Breakthrough Therapy status to Roche’s Actemra for systemic sclerosis, a connective tissue disease that is characterized by the hardening of the skin.
Actemra is already approved for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
Systemic sclerosis can scar organs and damage joints. Roche said in a statement that it has the highest mortality rate of any rheumatic disease.
The Breakthrough Therapy designation speeds drugs through the FDA review process and is applied to drugs that appear to offer a significant benefit over treatments that are currently on the market or that treat serious diseases for which no treatment is available.
Other Breakthrough Therapy drugs include Vertex’s cystic-fibrosis drug Kalydeco and Novartis’s cancer drug Zykadia.