Humira receives two European recommendations
pharmafile | June 29, 2005 | News story | Sales and Marketing |Â Â Â
Abbott's Humira has moved closer to European approval as a first-line treatment of moderate to severe early rheumatoid arthritis in Europe.
The novel rheumatoid arthritis (RA) therapy received a positive opinion from the CHMP, the EMEA's scientific advisory committee, based on results from a two-year trial.
Humira (adalimumab) also moved a step closer to European approval for the treatment of psoriatic arthritis following a recommendation from the CHMP.
Patients undertaking the placebo-controlled trials showed improvement in both arthritic and psoriatic symptoms.
Humira was the first human monoclonal antibody to receive European approval for the treatment of rheumatoid arthritis and has been described by Abbott as its most important product ever.
Its recommendation as a first-line treatment follows positive data from the phase III Premier study, where patients with early rheumatoid arthritis (RA) showed significant improvements in symptoms while taking Humira in combination with the standard therapy, methotrexate.
"The committee's recommendation signals that Humira will provide patients and physicians with another first-line treatment option to combat this potentially debilitating disease," commented Alejandro Aruffo, vice president of Abbott's global pharmaceutical research and development.
The two-year study compared the effectiveness of Humira, methotrexate and the combination of the two drugs, in adult patients with RA of less than three years who had not previously used methotrexate.
Abbott's drug is the third entrant in the TNF-blocker class, following Amgen and Wyeth's co-marketed Enbrel and Schering-Plough's market leading Remicade (marketed by Johnson & Johnson).
The EU Commission is expected to make a final authorisation decision on both recommendations within 90 days.
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