FDA Grants Breakthrough Therapy Designation for Actemra (tocilizumab) in Systemic Sclerosis

Industry News

Genentech, a member of the global pharmaceutical company Roche Group, announced that the U.S. FDA has granted Breakthrough Therapy Designation status to its Actemra® (tocilizumab) for the treatment of systemic sclerosis.  Systemic sclerosis is a rare autoimmune disease characterized by abnormalities in blood vessels and thickening of the skin caused by pathological accumulation of collagen.  It represents the highest mortality rate of any autoimmune rheumatic disease.  Currently, there is no cure for this disorder and no FDA-approved therapy either. Actemra is a humanized interleukin-6 (IL-6) receptor antagonist indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).  According to Genentech, the company has initiated a Phase III clinical trial to investigate the efficacy of Actemra in systemic sclerosis (NCT02453256).


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