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Roche submits Actemra for RA in US

Roche submits a biologics license application to the FDA seeking US marketing approval for Actemra for the treatment of moderate-to-severe rheumatoid arthritis in adults

Swiss pharmaceutical company Roche has submitted a biologics license application (BLA) to the FDA seeking US marketing approval for Actemra (tocilizumab) for the treatment of moderate-to-severe rheumatoid arthritis (RA) in adults.

Actemra is the first humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA.

Research suggests that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints and relieve certain systemic effects of RA.

The BLA submission is based on results from five international phase III studies, which tested Actemra as a monotherapy or in combination with disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate, on 4,000 patients in 40 countries.

Findings showed that Actemra significantly reduced the signs and symptoms of RA, as measured by ACR and disease activity score (DAS) remission rates, compared with DMARD therapies alone.

In addition, patients who had previously failed anti-tumour necrosis factor (anti-TNF) treatments also showed significant improvement in signs and symptoms of RA after treatment.

One of the phase III trials evaluating Actemra in RA is an ongoing two-year study and is expected to report one-year data evaluating the effect of the drug on the inhibition of structural damage in 2008.

William M Burns, CEO of the pharmaceuticals division at Roche, said: "The filing for Actemra in the US is an important milestone, and brings us another step closer to making this therapy available to the millions of patients in the who suffer from the pain and debilitating effects of rheumatoid arthritis."

Roche will file a Marketing Authorisation Application (MAA) for the product with the European Medicines Agency (EMEA) in early December 2007.

WestLB analysts expect Actemra to generate sales of at least CHF 2bn (USD 1.8bn) and placed an "Add" rating on Roche, whose shares rose sharply on the news, up 2.2 per cent at CHF 204.20 (USD 183.57).

30th September 2008

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