The breakthrough therapy status is designed to expedite the development and review of medicines intended to treat serious diseases as well as help ensure patients have access to them as soon as possible.
Separately, the company has also initiated a global Phase III trial in SSc, which is characterized by blood vessel abnormalities, as well as degenerative changes and scarring in the skin, joints and internal organs.
The breakthrough therapy status for Actemra/Roactemra was granted based on data from the Phase II faSScinate trial.
In addition, new data from the U-ACT-Early and Tender studies in patients with early rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (sJIA), respectively, as well as results from the Phase II faSScinate study in SSc will be presented at the annual congress of the European League Against Rheumatism (EULAR 2015).
Roche Global Product Development head and chief medical officer said: "Close to 500,000 people worldwide have benefited from treatment with Actemra/RoActemra since initial approval over a decade ago.
"The breadth of our study results at EULAR, ranging from arthritis in adults and children to a rare inflammatory disorder, underscores our commitment to helping people with debilitating autoimmune diseases.
"These new data further demonstrate the efficacy and safety of Actemra/RoActemra in multiple diseases, including use as a single therapy in early RA."
The company said that Actemra/Roactemra monotherapy and combination treatment regimens almost double sustained remission rates in people with early rheumatoid arthritis (RA).