Genentech has announced that the Food and Drug Administration (FDA) has accepted the company’s Supplmental New Drug Application (sBLA) for Actemra (tocilizumab) to treat giant cell arteritis (GCA).

Actemra, a humanized interleukin-6 (IL-6) receptor antagonist, is currently approved to treat patients with moderate to severe rheumatoid arthritis (RA) who had inadequate relief from using one or more disease-modifying antirheumatic drugs (DMARDs). 

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The FDA designation is based on the randomized, double-blind, placebo-controlled Phase III GiACTA study, which evaluated Actemra in people with GCA. Results showed that Actemra, initially combined with a 6-month steroid (glucocorticoid) regimen, had greater efficacy in sustaining remission through 1 year compared to a 6- or 12-month steroid taper regimen alone.

“We are pleased by the FDA’s decision to classify their review of the sBLA as priority. We will continue to work closely with the FDA to bring this investigational medicine to people with GCA as quickly as possible,” said Sandra Horning, MD, CMO of Genentech.

GCA can cause severe headaches, jaw pain, visual symptoms and if left untreated, can lead to blindness, aortic aneurysm or stroke. Treatment for GCA has been limited to high-dose steroids, however steroids are seen as an emergency treatment option and are often unable to maintain long-term disease control.

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