09/11 12:23 U.S. FDA approves rheumatoid arthritis drug
(Writes through with quotes, background)
By Maggie Fox, Health and Science Correspondent
WASHINGTON, Sept 11 (Reuters) - A new drug for rheumatoid arthritis,
which helps relieve symptoms but is a far cry from a cure, won approval on
Friday from the U.S. 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 <HOEG.F>, 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 <IMNX.O> Corp.
A second drug is infliximab, made by Centocor <CNTO.O> 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.
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