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FDA Approves Breakthrough Status To Expand Uses Of Roche Drug Actemra

Roche got the green light from the US Food and Drug Administration for its rheumatoid arthritis medication Actemra’s breakthrough status. The Swiss pharmaceutical company can now proceed with its plans to broaden the applications for the drug, including treating giant cell arteritis, Reuters reports.

Giant cell arteritis is the most common type of vasculitis in adults. It is a chronic autoimmune disease brought on by the inflammation of large and medium arteries, often in the head but also in the aorta and surrounding branches. Symptoms include headaches, fever, joint pain, facial pain, difficulties with vision, and permanent loss of sight in one or both eyes. It can be extremely dangerous and life-threatening, generally affecting people 50 years and older.

Given its rare occurrence and its ability to cause so many symptoms, the disease, can be difficult to diagnose. However, with appropriate medication, giant cell arteritis is controllable and curable.

The company got approval for Actemra in 2010 and continued researching new ways that it can be used to beat other autoimmune diseases. It is also known as RoActemra in Europe. A breakthrough therapy label from the FDA means reviews on Actemra’s benefits can be expedited, as the tag is used for drugs that establish potentially significant developments over other current therapies.

Actemra is the fifth best-selling treatment for Roche. Its sales in the first half of this year rose 17% to 814 million Swiss francs ($833 million), as physicians have been prescribing it for rheumatoid arthritis and juvenile idiopathic arthritis.

Chief Medical Officer Sandra Horning said,

The FDA Breakthrough Therapy designation for giant cell arteritis underscores our continued commitment to explore Actemra/RoActemra in autoimmune diseases with significant unmet need.

If successful, this would be the first new treatment for giant cell arteritis in close to 50 years.

In an earlier study, Roche reported that Actemra combined with a steroid regimen over six months was more effective at sustaining remission throughout a year, compared with steroids alone taken in six- or 12-month treatment periods.

The drug maker will present its complete study later in the year.

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