RoActemra approved in Europe
pharmafile | January 29, 2009 | News story | Sales and Marketing |Â Â RoActemra, RocheÂ
The European Commission has approved Roche's RoActemra as a treatment for rheumatoid arthritis.
Schering-Plough's Remicade, Wyeth's Enbrel and Abbott's Humira are the current leaders in the rheumatoid arthritis field, and are all in the anti-TNF class.
RoActemra works differently, and is the first interleukin-6 (IL-6) receptor-inhibiting antibody developed to treat the disease.
Analysts have predicted that RoActemra could break the $1 billion annual sales mark, but must first establish itself in one of pharma's most competitive markets.
Phase III studies show RoActemra (tocilizumab) on its own or in combination with methotrexate or other disease modifying drugs, reduced the signs and symptoms of the chronic, progressive disease.
RoActemra is indicated in combination with methotrexate for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA). RoActemra can also be given as monotherapy in cases of intolerance to methotrexate.
These patients will have responded inadequately, or been intolerant, to DMARDs or tumour necrosis factor (TNF) antagonists.
TNFs do not work for all patients, with around a third of patients failing to respond to them. Resistance to the TNFs is also regularly seen, meaning that some patients must be given higher doses to maintain their response.
"Many patients suffering from RA fail to respond to any treatment and few actually achieve lasting remission, which is currently the ultimate goal of treatment for RA," said William Burns, chief executive of Roche's pharmaceuticals division.
Although the exact cause of RA is unknown – and there is no cure at present – IL-6 is one of several proteins which help cause the joint inflammation which is so debilitating for sufferers.
Data from 2008's LITHE trial showed the drug increases RA remission rate and slows the disease's destruction of joints.
In the US last year, regulators recommended the drug for moderate to severe RA, but the authorities have since asked for more information on the drug's manufacture and labelling.
Known as Actemra outside the EU, the drug was developed by Roche and its part-owned Japanese subsidiary Chugai. Already approved in Japan for RA, it is also licensed there for polyarticular-course juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis. It has also gained approval in India and Switzerland.
Roche has great hopes for its work in autoimmune diseases with RA as the first indication.
It also markets MabThera, the first selective B-cell therapy for RA, targeting B cells which are one of the key players in the pathogenesis of the condition.
Roche also has a humanised anti-CD20 antibody called ocrelizumab in phase III for RA along with other compounds in phase I, II and III clinical trials.
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