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Basel, 24 January 2017

FDA grants priority review for Roche’s Actemra/RoActemra (tocilizumab) supplemental biologics license application for giant cell arteritis, a form of vasculitis

Roche recently announced positive results from a Phase III clinical trial in giant cell arteritis (GCA)

There have been no new therapies for GCA in more than 50 years

Breakthrough therapy designation was granted to Actemra/RoActemra for the treatment of GCA by the FDA in 2016

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental biologics license application (sBLA) for Actemra/RoActemra (tocilizumab) for the treatment of GCA, a chronic, potentially life-threatening autoimmune condition. The FDA also granted priority review designation for Actemra/RoActemra for the treatment of GCA. The designation is based on the positive outcome of the Phase III GiACTA study evaluating Actemra/RoActemra in people with GCA. Results showed that Actemra/RoActemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid taper regimen given alone in people with GCA.1

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It has been mentioned a few times on the forums. Unfortunately - it doesn't mean it is available in the UK for management of GCA yet. There was a consultation last summer (before the study reported) which resulted in the decision tocilizumab may be used for Takayashu's arteritis (identical to GCA but with confirmed aortic involvement and found in younger patients) but not for GCA. Which to me smacks of ageism but hey-ho... They did, however, mention that they would reconsider if further evidence came forward - it did, with the results of the GiACTA study.

There are doctors in the USA and Australia using it - but off-label at present.


What good news! I am presently on Actemra infusions for a recent flare up in GCA. I am hopeful for a remission when I am through with the Actemra. I am also on Prednisone 40 mg, and hope to start decreasing the Prednisone.

I so hope Actemra will be available to all GCA patients who need it. ❤😍

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