There was a burst of good news for Abbott Laboratories yesterday after its rheumatoid arthritis drug, Humira (adalimumab), was approved for two new indications in the USA and submitted for approval in a third.
The US Food and Drug Administration granted approval of the anti-tumour necrosis factor antibody in the first-line treatment of patients with moderate-to-severe rheumatoid arthritis. This was swiftly followed by the announcement that the FDA had also cleared Humira to relieve symptoms in patients with psoriatic arthritis, a chronic disease that combines the symptoms of arthritis, including joint pain and inflammation, with those of psoriatic skin disease, such as dry, scaly skin. It has already been cleared for both of these indications in Europe [[16/08/05b]].
Humira was first approved in 2002 to treat patients with moderate to severe RA in 2002, but to date has been indicated only for use in patients who had had insufficient response to one or more other disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate. The antibody brought in revenues of $321 million dollars in the second quarter of this year, up nearly 60% [[14/07/05c]], an impressive growth rate considering it competes with big-selling established drugs such as Amgen/Wyeth's Enbrel (etanercept) and Johnson & Johnson's Remicade (infliximab).
However, analysts have suggested Humira’s momentum has started to falter, so the new indications are timely. Abbott believes they will help the drug achieve sales of $1.3 billion this year, a welcome development given the FDA's recent rejection of its application to market Xinlay (atrasentan), a drug for prostate cancer [[14/09/05c]].
Meanwhile, Abbott said that it has simultaneously filed dossiers in support of Humira in the treatment for ankylosing spondylitis, an inflammatory disease of the spine and spinal joints, with the FDA and European Medicines Agency. The company is also developing Humira for Crohn's disease and psoriasis [[18/05/05d]] [[10/02/04c]].