Abbott receives positive CHMP opinion for Humira

Abbott has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for Humira (adalimumab) as a treatment for moderate for severe plaque psoriasis, the fifth indication for the compound.

It previously announced that it had applied for approval in this indication during April of this year and the firm is now waiting for approval from the European Commission and US Food and Drug Administration.

The positive opinion for Humira is mainly based on the results of the Reveal and Champion randomised trials in adult patients which saw the signs and symptoms of psoriasis assessed using the Psoriasis Area and Severity Index.

Eugene Sun, vice-president of global pharmaceutical clinical development at Abbott, said: “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 Humira, a much anticipated treatment option for this condition.”

Professor Jean-Hilaire Saurat, chairman of the department of dermatology at the University of Geneva said that the physical and emotional distress caused by the plaques and scales of psoriasis mean that it is vital to discover new treatment options for the condition.

Earlier this month, Abbott released a new study assessing the rate of uveitis in ankylosing spondylitis patients administered with Humira.