Abbott Laboratories has received yet more good news about Humira as European regulators have recommended approval of the tumour necrosis factor blocker as a treatment for psoriasis.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted Abbott a positive opinion recommending approval of Humira (adalimumab) for the treatment of moderate to severe plaque psoriasis. If fully approved, a move which is more than likely to happen in the next two months, psoriasis will be the fifth disease indication for Humira.

The recommendation was based on two studies, REVEAL and CHAMPION. In the first, 52-week, 1,200-patient trial, patients experienced a significant reduction in the signs of their disease at 16 weeks when treated with the drug and almost three out of four patients receiving Humira achieved PASI (the Psoriasis Area and Severity Index which measures the severity of the condition) 75 or better, compared to only 6.5% of patients receiving placebo. In CHAMPION, a 16-week study evaluating 271 patients, 80% of those treated with Humira achieved PASI 75 compared to those on methotrexate (36%), a standard treatment for psoriasis, and four times more than patients treated with placebo.

Eugene Sun, vice president of global clinical development at Abbott, said that "the skin clearance we have seen in Humira psoriasis clinical trials, combined with ten years of clinical experience across indications and the convenience of self-injection”, make it a “much-anticipated treatment option for this condition". The company is hoping for approval shortly from the US Food and Drug Administration approval for this indication as well.

Humira, which is already approved for the treatment of rheumatoid and psoriatic arthritis, as well as ankylosing spondylitis and Crohn’s disease, had third-quarter sales of $803 million, up 48.5%, and a psoriasis approval can only push that figure up further.