US drugmaker Abbott Laboratories is seeking approval on both sides of the Atlantic to market its top-selling arthritis drug Humira for the treatment of Crohn’s disease.
The company said yesterday it has submitted simultaneous filings to the US Food and Drug Administration and the European Medicines Agency, based on strong clinical data from three randomized, double-blind, placebo-controlled, multi-centre trials, which demonstrated that Humira (adalimumab) was able to induce and maintain clinical remission in patients with moderate-to-severe Crohn's.
The drug, which is already on the market for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, pulled in sales of $1.4 billion in 2005, a figure which looks set to grow to just under $2 billion this year. Over a million people in Europe and the US suffer from Crohn's - a chronic inflammatory disorder of the gastrointestinal tract - so approval for this indication could substantially boost Humira’s already enviable sales.
As yet, there is no cure for Crohn’s, reinforcing the need for safe and effective therapies to help patients control their disease, Abbott notes.