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Humira approved in the EU for Crohn's disease

Abbott has received marketing authorisation from the EU Commission for the use of Humira as a treatment for severe Crohn's disease

US pharmaceutical company Abbott has received marketing authorisation from the EU Commission for the use of Humira (adalimumab) as a treatment for severe Crohn's disease.

Crohn's disease causes inflammation of the gastrointestinal (GI) tract and affects more than one million people in North America and Europe. It is mainly a disease of young adults, with onset before 40 years of age. There is no medical or surgical cure for Crohn's disease and few treatment options exist.

The recent approval was based on data from three pivotal trials of Humira in more than 1,400 adult patients with moderately to severely active Crohn's disease. The CLASSIC I, CHARM and GAIN trials evaluated the efficacy and safety of the drug in a group of moderate to severe adult Crohn's disease patients, from those who had not received anti-tumor necrosis factor alpha (TNF-alpha) therapy, to patients who had previously lost response or were unable to tolerate infliximab, an anti-TNF agent.

The CLASSIC I induction trial evaluated Humira for the induction of clinical remission. Of the 299 anti-TNF naive patients, 36 and 24 per cent of patients receiving the drug achieved clinical remission at week four compared to 12 per cent treated with placebo.

The 56-week CHARM trial studied Humira for the maintenance of clinical remission in 854 patients with moderate to severe Crohn's disease. After a four-week open label induction phase during which all subjects received 80mg at week zero followed by 40mg at week two, 58 per cent of patients demonstrated clinical response. Of those who continued on 40mg every other week, 40 per cent were in clinical remission at week 26 and 36 per cent were in remission at week 56, compared with 17 per cent and 12 per cent of patients in the placebo group, respectively. For those who continued taking 40mg weekly, 47 per cent were in clinical remission at week 26 and 41 per cent were in remission at week 56.

In GAIN, a four-week induction trial of 325 patients who lost response or were intolerant to infliximab, three times as many patients taking Humira achieved clinical remission at week four versus placebo.

Humira is the first self-administered biologic for the treatment of Crohn's disease. The announcement follows FDA approval for the indication, which Abbott received in February 2007, and is the fourth approved indication for Humira in the US and the EU.

In the EU, the recommended Humira induction dose for adult patients is 80mg at week zero followed by 40mg at week two. If there is a need for a more rapid response to therapy, patients can take 160mg at week zero, followed by 80mg at week two, with the awareness that the risk for adverse events is higher during induction.

Q1 FY07 sales for Humira in the US were USD 289m, up 32 per cent on Q1 FY06 figures. Total global sales for the same time period were USD 571m, an increase of 45.6 per cent on Q1 FY06.

Bank of America analysts have stated their concerns over Humira's performance for Q1 FY07. Humira sales were USD 35m short of their estimate, but they added they were encouraged by Abbott's reaffirmation that FY07 global sales would exceed USD 2.7bn.

14th June 2007

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