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Home Industry News Abbott receives EU approval for Humira

Abbott receives EU approval for Humira

21st December 2007

Abbott has confirmed that Humira has received marketing authorisation from the European commission for the treatment of moderate-to-severe plaque psoriasis.

This latest decision by the European Union marks the fifth approved indication for Humira in Europe with the drug’s use in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’s disease already authorised.

Abbott submitted its regulatory application for the use of Humira in moderate-to-severe plaque psoriasis after clinical trials demonstrated positive results.

In one clinical trial, it was found that more than 80 per cent of patients taking Humira achieved skin clearance of 75 per cent or better, while another study revealed that three-quarters of patients achieved 75 per cent clearance.

Eugene Sun, vice-president of global pharmaceutical clinical development at Abbott, stated that patients taking Humira for psoriasis had experienced rapid and maintained skin clearance.

”This fifth indication for Humira demonstrates its versatility in effectively treating multiple autoimmune disorders from rheumatoid arthritis to Crohn’s disease and now psoriasis,” he added.

Last month, Abbott released a new study examining the rate of uveitis (inflammation of the eye) in ankylosing spondylitis (AS) patients who had been treated with Humira.

The study found that AS patients treated with Humira showed a decrease in the rate of uveitis flares by around 50 per cent compared to patients treated with a placebo.

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