Abbott announces positive CHMP opinion for Humira

Abbott has announced that Humira (adalimumab) has been granted a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency as a treatment for Crohn’s disease.

This positive opinion is a result of three clinical trials, the first and third showing treatment in Humira resulting in an increased rate of clinical remission in patients, the second showing increased maintenance of clinical remission through one year.

Humira operates by blocking tumour necrosis factor, a protein that plays a role in the body’s response to immune-mediated diseases. The compound is currently indicated as a treatment for ankylosing spondylitis, psoriatic arthritis and rheumatoid arthritis.

Abbott forecast that the drug will be granted marketing authorisation in Europe as a treatment for Crohn’s disease within the next 60 days.

Eugene Sun, vice-president of global pharmaceutical clinical development at Abbott, said: “The expected European approval of Humira for the treatment of Crohn’s disease represents a much anticipated option for physicians and patients.”

He added that, as the sole self-injectable biologic treatment for the condition, the compound offered patients convenience and sustained response.

Earlier this month, Abbott announced the opening of a manufacturing facility in Puerto Rico for the long-term supply of Humira.