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Humira one step closer to European market

Published on 29/10/03 at 09:59am

Abbott Labs' human monoclonal antibody Humira has received a positive opinion from the EMEA for the treatment of rheumatoid arthritis, the first such drug to do so in Europe.

The novel therapy was developed in collaboration with Cambridge Antibody Technology and was launched in the US at the start of the year after the FDA gave approval several months earlier than anticipated.

The drug which Abbott has described as the most important product it has ever produced recorded sales of $26 million in the first quarter of the year, but heavy promotional spending led to the company recording a 6% drop in profits.

Humira, a tumour necrosis factor alpha inhibitor, is indicated as a monotherapy or combination treatment with methotrexate.

Abbott said the drug would be available in the UK and Germany within two weeks of receiving approval, which it expects within three months. Further European roll-outs will take place in subsequent months.

The company is, however, facing potential legal action from CAT over royalties on the drug.

"The availability of Humira is extremely important for the many RA patients who may not be seeing adequate results from their current medications", said Guillermo Herrera, Senior VP, International Operations, Abbott. "We're pleased the proposed indication provides physicians with the opportunity to prescribe Humira with methotrexate or as monotherapy, depending upon the need of the individual patient".

Johnson & Johnson and Schering-Plough's rival arthritis treatment Remicade has, meanwhile, received European regulatory approval for two new indications ankylosing spondylitis (AS), which affects the spine, and the bowel condition Crohn's disease.

Thomas Lauda, Executive VP, Schering-Plough Pharmaceuticals, said: "Remicade continues to demonstrate its effectiveness in treating serious immune disorders and we are committed to further studying its benefits in order to maximize its value for patients.

Remicade was approved to treat AS as a second-line treatment where patients have not responded adequately to standard pain and anti-inflammation drugs. It was also given clearance for 'maintenance dosing' to control severe Crohn's disease symptoms in those patients who have previously responded to the medicine.

Schering-Plough holds world-wide rights to Remicade outside the US, Japan and some other parts of Asia. Sales of the drug increased by 89% to $114 million in the first quarter of this year in these areas.

In the US, Remicade is marketed by Johnson & Johnson through its Centocor subsidiary, and its sales in that territory jumped by 67% in the first quarter to $409 million.

Genentech and Xoma have ceased development of their humanised monoclonal antibody Raptiva for the treatment of moderate to severe rheumatoid arthritis.

Phase II data indicated Raptiva which is seeking both US and EU approval for its primary indication, psoriasis offered no overall clinical benefit when taken with methotrexate over placebo.

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