According to an earlier study whose results were announced in June, Roche said Actemra/RoActemra initially combined with a six-month steroid regimen more effectively sustained remission through one year compared with a six- or 12-month steroid-only regimen in people with GCA.
The company plans to present full data from the study later this year.
Roche chief medical officer and head of global product development Sandra Horning said: “We are looking forward to working with the FDA in the hope of making Actemra/RoActemra available to people with GCA, a condition for which there has been no approved treatment in more than 50 years.”
Actemra/RoActemra is claimed to be the only approved anti-IL-6 receptor biologic, available in both intravenous (IV) and subcutaneous formulations, to treat adult patients with moderate to severe active rheumatoid arthritis (RA).
It can be used alone or with methotrexate (MTX) in adults who are intolerant to, or have failed to respond to, other anti-rheumatic medications.
Actemra/RoActemra, which is approved in 115 countries, is also being evaluated in a global phase III study for patients with systemic sclerosis (SSc).
The FDA granted breakthrough therapy designation for Actemra/ RoActemra for SSc in June 2015.
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