FDA APPROVES RHEUMATOID ARTHRITIS DRUG

WASHINGTON (Reuters) - A new drug for rheumatoid arthritis, which
helps relieve symptoms but is a far cry from a cure, won approval
Friday from the Food and Drug Administration.

The FDA warned that Arava is also too dangerous to use in pregnancy --
bad news for many of the estimated two million rheumatoid arthritis
sufferers in the country, most of whom are women.

Nonetheless, the agency was encouraged by studies that indicate Arava
can help prevent some of the damage that rheumatoid arthritis causes
to joints, and sped the drug through its approval process.

``Although the drug does not cure rheumatoid arthritis, it has been
shown in clinical trials to provide relief for painful, swollen joints
caused by rheumatoid arthritis and to retard damage to joints,'' the
FDA said in a statement.

More than five million people around the world suffer from rheumatoid
arthritis, caused when the body's immune system mistakenly turns
against the joints. No one know why this happens but scientists
suspect an infection may be to blame.

It usually strikes young -- between the ages of 20 and 50 -- and can
cripple a person as the joints are destroyed.

Hoechst Marion Roussel, which makes Arava, hopes the drug can be given
to patients very early on so their joints do not suffer permanent damage.

``Studies have shown that structural joint damage often starts during
the first two years after disease onset, so early diagnosis and
treatment are critical,'' Dr. Michael Schiff of the Denver Arthritis
Center, who tested the drug, said in a statement.

Dr. John Hyde, acting deputy director for the FDA division responsible
for the drug's approval, said it will be very carefully labeled.

Studies have shown it can cause birth defects in animals, so Arava
should never be used by pregnant women, he said. It can also cause
liver damage, diarrhea and hair loss. Doctors will be told to
carefully monitor the liver enzymes of patients taking Arava to check
for signs of damage.

``There's certainly reason to be prudent with it,'' Hyde said in a
telephone interview. ``It has a very long half-life so if someone is
taking the drug, even after they stop it it will hang around a while.''

A cholesterol-lowering drug can be used to take Arava out of the
system of a woman who wants to become pregnant or who finds out she is
pregnant, Hyde added.

Hyde said Arava is comparable to methotrexate, a drug widely used to
treat the symptoms of rheumatoid arthritis.

``But this one (Arava) acts against progression of disease,'' he
added. ``It was such good data for an essentially new indication
(that) we gave it priority status.''

Arava, known generically as leflunomide, is thought to act early in
the disease process, blocking the accumulation of cells that cause
inflammation. But Hyde admitted that no one really understands just
how the drug works.

Other drugs used to treat rheumatoid arthritis include
glucocorticoids, such as cortisone, injections of gold, and drugs that
suppress the immune system.

Other companies are working to get new rheumatoid arthritis drugs to
market. Next week, doctors who advise the FDA will hear about Enbrel,
which works against some of the agents in the body responsible for
inflammation.

It is made by Immunex Corp.

A second drug is infliximab, made by Centocor and sold under the name
Remicade, formerly Avakine, for the treatment of Crohn's disease, an
inflammation of the bowel. The company also wants to use the drug
against rheumatoid arthritis.

Checked-by: Patrick Henry