By Lisa Richwine
GAITHERSBURG, Md., Jul 13 (Reuters) - Anti-inflammatory drug Remicade, made
by Johnson & Johnson unit Centocor, reduces structural damage from rheumatoid
arthritis, a US advisory panel said Wednesday.
But the advisory committee did not vote on the company's proposed claim that
Remicade could prevent future joint damage from the disease, which is marked by
painful, swollen joints. The Food and Drug Administration will decide exactly
how the label will describe the drug, a key factor in how Centocor can promote
the product.
Dr. Lee Simon, the panel's acting chairman, said Centocor's study showed
"compelling" evidence that giving patients Remicade in addition to methotrexate,
a standard treatment, reduced joint damage over one year when compared to
patients who received methotrexate and a placebo.
Panel members were divided, however, on whether Centocor should be able to
advertise that Remicade prevents additional joint damage from the disease, which
afflicts more than 2 million Americans, most of them women. Some worried that
patients might think their disease would never progress, but studies only showed
how the drug worked for one year.
"You can prevent for a year, but it says nothing about five years," said Dr.
Barbara White of the University of Maryland School of Medicine.
Centocor was hoping to gain a marketing edge over two competing products.
Last month, the FDA gave Immunex Corp. permission to market its rheumatoid
arthritis drug Enbrel as a treatment that could delay the progress of joint
damage.
Another drug, Arava by Aventis SA , is approved for "retarding" the advance
of rheumatoid arthritis.
"I'm very confident we'll be able to adequately present data to the
prescribing community and physicians," Harlan Weisman, Centocor's senior vice
president for research and development, said in an interview. "Nobody (on the
panel) questioned the results."
Remicade, on the market since August 1998, is approved for treating patients
with rheumatoid arthritis who do not respond to methotrexate and for the bowel
disorder Crohn's disease. Both Remicade and Enbrel work in a similar manner by
inhibiting tumor necrosis factor, a protein linked to inflammation.
Centocor presented evaluations of X-rays of patients' hands, feet and
wrists.
The company said the study of 340 patients clearly showed that joint erosion
and the narrowing of spaces between joints did not progress after 54 weeks in
most patients taking Remicade. By contrast, patients in the placebo group did
show additional damage.
Remicade "unequivocally alters the course of rheumatoid arthritis," said Dr.
Gregory Harriman, senior director of Centocor's clinical research on immunology.
Possible side effects of Remicade, which is given by infusion, include
infections, headaches and rashes. The drug costs about $11,000 the first year
and about $9,000 each year after that, a Centocor spokesman said.
American Home Products Corp.'s Wyeth-Ayerst Laboratories co-markets Enbrel
in North America.
