Abbott: Another Promising Year for Humira

Abbott is seeking approval to market Humira as a treatment for juvenile rheumatoid arthritis in the US and EU, where it is already approved as a therapy for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. An approval in this new indication, in addition to an expected approval for Crohn’s disease in the EU, will help drive the drug’s commercial success in both markets.

Juvenile rheumatoid arthritis (JRA), referred to as juvenile idiopathic arthritis in the EU, is the most common type of pediatric arthritis, affecting approximately 50,000 children in the US alone. As with adult arthritis, the trend has been towards aggressively treating the disease as early as possible so as to minimize lasting affects.

In the early stages of the disease nonsteroidal anti-inflammatory drugs and analgesics, such as Tylenol, may be used relieve pain. In addition to painkillers, it is important to get patients started quickly on a targeted second-line, or disease modifying agents, in order to slow the progression of the disease and minimize joint damage.

Disease-modifying anti-rheumatic drugs (DMARDs), which work by directly targeting the immune system to reduce inflammation, are the most commonly used therapy in combination with painkillers. However, in a small percentage of patients DMARDs prove to be too slow to work or entirely ineffective, in which case biologics such as Humira (adalimumab) are commonly prescribed.

Biologics interfere with the abnormal immune responses that cause arthritis by inhibiting the actions of specific inflammatory cytokines. Because their mechanism of action is more directed than that of DMARDs they can be highly effective in patients that have not responded to more traditional disease-modifying drugs.

The effectiveness of biologics, combined with the fact that Humira is relatively easy to use or administer, has contributed to the success of the drug. Humira is Abbott’s first drug to reach $2 billion in annual sales and shows great promise to continue to develop within the market.

In 2006, Humira indications in the US were expanded to include ankylosing spondylitis, a form of arthritis that affects the spine. In the same quarter, Abbott released a one-touch injection pen, which makes it easy for patients to self-administer Humira. This year promises to be another growth year for the drug as an approval for juvenile rheumatoid arthritis would mark the first pediatric indication for Humira. Furthermore, Abbott has gained approval to market Humira for Crohn’s disease in the US, with entry into the EU markets anticipated before long.