FDA Approves Centocor's
Remicade As First-Line Rheumatoid Arthritis Therapy
WASHINGTON (Reuters Health) Jan 02 - The US Food And Drug Administration(FDA)
has approved Centocor Inc.'s Remicade (infliximab) for combination use with
methotrexate as a first-line therapy to inhibit the progression of structural
damage in patients with moderate-to-severe rheumatoid arthritis, the company
said on Tuesday.
The agent was approved in October 1999 as a second-line treatment for rheumatoid
arthritis in patients who have had an inadequate response to methotrexate alone,
which is the standard therapy for treating the disease.
Clinical studies of Remicade have demonstrated that the drug slows
rheumatoid arthritis-related joint damage by inhibiting its two contributing
causes; joint erosion and the narrowing of the joint space between the bones
In a study that followed 428 patients with rheumatoid arthritis, 52%
receiving Remicade and methotrexate reported a decrease in signs and symptoms of
the disease, including pain, stiffness and swollen joints, compared with 17% of
patients given methotrexate alone, the company said in a news release.
Centocor, a wholly owned subsidiary of Johnson & Johnson, estimates that the
cost of treating rheumatoid arthritis with Remicade runs between $10,000 and
$12,000 per patient, compared with $1,000 for methotrexate alone.
Side effects of Remicade, which was initially approved by the FDA in 1998 for
the short-term treatment of Crohn's disease, include upper respiratory
infection, headache, mild infusion-related reactions, sinusitis, rash and cough.
The drug's labeling stresses that the physicians should use caution in
prescribing the drug in patients with a chronic infection or with a history of
Potentially fatal infections including sepsis and disseminated tuberculosis have
been reported in patients using Remicade, particularly in those on concomitant
immunosuppressive drugs, the product's label warns.
Separately, 28 people throughout North America and Europe have developed
tuberculosis--and one patient died--after they were given Remicade, the European
Agency for the Evaluation of Medicinal Products (EMEA) reported.
In a public statement dated December 20, the EMEA said: "To date, 28 cases
of TB have been reported (nine cases in North America and 19 cases in Europe) of
which one had a fatal outcome.... "
"In a significant proportion, the onset of active TB occurred after three
or less infusions of Remicade, thus supporting a possible relationship with
initiation of Remicade therapy," the agency added.
The EMEA said that in view of the seriousness of these reports, it was
recommending that Remicade treatment should be stopped if active TB was
suspected in any patient until the diagnosis was ruled out or the infection had
Around 100,000 patients worldwide have taken Remicade since it was launched in
the United States in August 1998 and since it received European marketing
authorization in August 1999.
The drug is marketed by Schering-Plough in Europe and by Johnson & Johnson
in the United States.
Despite the approval, shares in Centocor dipped 2-7/16, or slightly more than
4%, to 54-5/16 in late-afternoon trading on the New York Stock Exchange.
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