Genentech (RHHBY) Receives FDA Breakthrough Therapy Designation for Actemra as Giant Cell Arteritis Treatment

October 5, 2016 6:20 AM EDT
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Genentech, a member of the Roche Group (OTC: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra® (tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The disease is caused by inflammation of large and medium-sized arteries, most often in the head, but also in the aorta and its branches.1

“The FDA Breakthrough Therapy Designation for GCA underscores our continued commitment to explore Actemra in autoimmune diseases with significant unmet need,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “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.”

Breakthrough designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible. This is the fourteenth Breakthrough Therapy Designation granted to Genentech since 2013, and the second for Actemra.

In June of this year, Genentech announced the positive outcome of the Phase III GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid-only regimen in people with GCA. Full data will be presented at an upcoming medical meeting in 2016.

About Giant Cell Arteritis

The prevalence of GCA has been estimated at over 200 per 100,000 persons in the U.S. over the age of 50, and the disease is two to three times more likely to affect women than men.1,2 GCA is often difficult to diagnose because of the wide and variable spectrum of signs and symptoms. GCA can cause severe headaches, jaw pain and visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke.1 Treatment to date for people with GCA has been limited to high-dose steroids that play a role as an effective ‘emergency’ treatment option to prevent damage such as vision loss. However, steroids do not always maintain long-term disease control (flare-free remission)3,4,5. Due to the variety of symptoms, complexity of the disease and its complications, people with GCA are often seen by several physicians including rheumatologists, neurologists and ophthalmologists.



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