Abbott's Humira wins OK to treat juvenile arthritis

February 23, 2008

February 23, 2008

Abbott Laboratories said Friday that its top-selling drug, Humira, has won

approval from federal regulators to treat juvenile rheumatoid arthritis.

This is the sixth use for Humira approved by the Food and Drug

Administration and the second this year, the North Chicago-based company

said.

Humira, with $3.1 billion in 2007 sales, is the first new biologic treatment

for the illness in almost 10 years, according to Abbott spokeswoman

Shea. The approval allows Humira to challenge Amgen Inc.'s Enbrel,

which is taken once or twice a week. Humira is taken once every two weeks.

Abbott said Humira is used by more than 250,000 people worldwide. The drug

is approved in the U.S. to treat rheumatoid arthritis; psoriatic arthritis;

ankylosing spondylitis, a spinal disorder; psoriasis; and Crohn's disease, a

bowel disorder.

Abbott forecast sales of more than $4 billion this year. Shea declined to

say how much the new approval might add to revenue.

Although both Enbrel and Humira have risks of side effects and infections,

only the Abbott drug's prescribing literature currently carries a warning in

a black box, the most serious caution required by the FDA, alerting users to

a small risk of serious infections, including tuberculosis.

Amgen and the FDA are discussing safety concerns for Enbrel and other drugs

in its class, which could result in a boxed warning, Amgen said in its most

recent quarterly report to the Securities and Exchange Commission.

Juvenile rheumatoid arthritis includes common types of arthritis in children

that result in swollen joints and pain, according to the National Institutes

of Health.

It appears in most patients before they turn 16. Symptoms include fever,

back pain, joint pain and growth abnormalities.

The FDA's approval was based on a study that found children with the disease

were twice as likely to achieve 70 percent improvement of their symptoms as

patients receiving a placebo, and were about a third less likely to

experience a flare-up of the disease.

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