Roche’s RoActemra recommended for approval
pharmafile | November 26, 2008 | News story | Sales and Marketing |Â Â RA, RocheÂ
European regulators have recommended Roche's RoActemra be approved to treat moderate to severe rheumatoid arthritis.
The novel drug, known as Actemra outside the EU, is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody developed to treat the disease.
Key regulatory advisory committee the CHMP says it should be used in combination with methotrexate (MTX) in adults who have not responded to one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
Where these patients are intolerant to MTX, or where continued treatment with MTX would be inappropriate, RoActemra could be used as a monotherapy.
Recommendations by the CHMP are generally followed by the European Commission when it comes to licensing new products.
The CHMP's positive opinion was based on results from five phase III studies which said RoActemra, on its own or in combination, significantly reduced RA signs and symptoms, compared with current DMARDs alone.
The most recent data last month from the LITHE trial showed the drug increases RA remission rate and slows the disease's destruction of joints.
Rheumatoid arthritis (RA) is a chronic, progressive inflammatory disease of the joints and tissues causing severe pain and irreversible joint damage.
The humanised monoclonal antibody inhibits the activity of IL-6, one of several key proteins involved in causing the inflammation in the membrane that lines joints.
Three anti-TNFs – Schering-Plough's Remicade, Wyeth's Enbrel and Abbot's Humira – are the current big hitters in the RA market, although Roche is establishing itself too and already markets MabThera, the first B-cell therapy for RA.
The chief executive of Roche's pharma division William Burns called the CHMP's decision "an important step forward in the fight against this debilitating disease".
In the US regulators recently recommended Actemra for adults with moderate to severe RA, but the authorities have since asked for more information on the drug's manufacture and labelling.
RoActemra was developed by Roche and Japanese company Chugai. The drug was launched by Chugai in Japan three years ago as a treatment for Castleman's disease.
Last April it was also approved for RA, polyarticular-course juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis in the country.
RoActemra is generally well tolerated, with the most common adverse reactions upper respiratory tract infection, nasopharyngitis, headache and hypertension.
Serious reactions reported include gastrointestinal perforations and hypersensitivity reactions including anaphylaxis.
Roche has compounds in phase I, II and III clinical trials for use with RA. Chief among these is ocrelizumab, a humanised anti-CD20 antibody which has entered phase III.
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