ACTEMRA Gets "Breakthrough" Status from the FDA for Scleroderma Save
The FASSCINATE study presented at EULAR 2015 was instrumental in tocilizumab (TCZ) getting a nod from the FDA to develop TCZ for scleroderma. “This Breakthrough Therapy Designation underscores the unmet need in systemic sclerosis and the potential of Actemra to help patients with this debilitating autoimmune disorder, ” said Dr. Sandra Horning, chief medical officer and head of Global Product Development. Breakthrough therapy designation from the FDA is expected to expedite the development and review of drugs that are intended to treat serious diseases and to provide access to patients as soon as possible.
The FASSCINATE Actemra study included 87 PSS patients and showed showed improved skin scores and significantly better FVC measures in those treated with tocilizumab.
Another phase III trial is being planned.