Advisory Panel recommends Actemra to FDA

Actemra, Roche's rheumatoid arthritis drug candidate, received backing by a government advisory panel of medical experts who spoke to the FDA regarding its risks and benefits. The panel recommended the medication, although there have been some concerns about its safety.

Roche promotes the medication as a new type of rheumatoid arthritis treatment aimed at individuals with moderate or severe cases of the condition. Rheumatoid arthritis is an autoimmune disease that leads to a painful--and often debilitating--swelling of the joints. Clinical trials showed improved laboratory test results and less severe symptoms in patients using the drug, which works by blocking the effect of interleukin 6 (IL-6), a protein involved with the inflammatory process. Patients undergoing treatment receive the medication intravenously about once a month.

Concerns about the Actemra's safety have arisen due to reports of associations with liver problems, malignancies and serious infections, which are likely associated with the drug's immunosuppressive actions. The drug is already in use in Japan and its efficacy was not as much of a concern as its safety profile during the talk.

If approved, analysts say they expect Acterma to bring in anywhere from about $800 million to $4 billion annually for Roche.

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