FDA Announces Breakthrough Therapy Designation for Promising New Giant Cell Arteritis Medication

Genentech, the South San Francisco based biotechnology company, has announced action by the US Food and Drug Administration granting Breakthrough Therapy Designation status to a new treatment for giant cell arteritis (GCA). The designation is for the company’s product, Actemra® (tocilizumab), and is the 14th Breakthrough Therapy Designation granted to the organization since 2013. The designation is intended to expedite the process of medication development and review when early evidence of potential clinical benefit is identified. Such evidence was provided by Genentech in June, with the return of positive results from the Phase III GiACTA study of Actemra in patients with GCA.

GCA is a chronic autoimmune disorder caused by inflammation of large and midsized arteries in the head and the aorta and its branches. Patients can suffer severe headache and jaw pain, and are at potential risk for blindness, aortic aneurysm, or stroke. The condition is difficult to diagnose, and treatment options to date have been limited to high-dose steroids that are not fully effective in preventing remission. Actemra is an interleukin-6 (IL-6) receptor antagonist currently approved for treatment of moderate to severe rheumatoid arthritis. Sandra Horning, MD, Genentech’s chief medical officer and head of Global Product Development, said of the FDA action, “We are looking forward to working with the FDA in the hope of making Actemra available to people with GCA, a condition for which there has been no approved treatment in more than 50 years.”

A news story about the FDA action, with additional information about Actemra, may be read here.



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