NEW YORK, Oct 18 (Reuters) - Abbott Laboratories Inc. (ABT.N: Quote,
Profile, Research) on Monday said its arthritis drug, Humira, proved
effective in treating arthritis associated with the skin disorder psoriasis
in a late-stage clinical trial.
Humira is already sold as a treatment for rheumatoid arthritis. Abbott said
it would use the new data to seek approval from U.S. and European regulators
to treat psoriatic arthritis by the end of this year.
The company has forecast 2005 global Humira sales in excess of $1.2 billion.
Approval for the new indication would likely come in late 2005, the company
said.
Psoriatic arthritis is an autoimmune disorder that combines symptoms of
psoriasis, such as dry, scaly skin, with arthritis symptoms such as joint
pain and inflammation.
Amgen Inc. (AMGN.O: Quote, Profile, Research) , which has a similar
arthritis drug, Enbrel, has already received U.S. approval to sell the
medicine for psoriatic arthritis.
In the study, which will be presented on Tuesday at the American College of
Rheumatology annual meeting in San Antonio, Texas, patients taking Humira
showed significant improvement in both joint and skin symptoms, compared
with those taking a placebo, researchers said.
The 313 patients in the trial had previously failed to show improvement when
treated with non-steroidal anti-inflammatory drugs, such as Motrin or
ibuprofen.
The primary goal of the trial was to show a 20 percent improvement in tender
and swollen joint count, or ARC20.
At 24 weeks, 39 percent of patients treated with Humira achieved a 50
percent improvement (ACR50) and 23 percent reached ACR70, compared to six
percent and one percent in the placebo group.
For psoriasis symptoms, 42 percent of Humira patients experienced at least
90 percent improvement at 24 weeks. Zero percent achieved 90 percent
improvement in the placebo group, researchers said. One percent of the
placebo group reached 75 percent improvement
Nann Bell - 20 Oct 2004 06:21 GMT
> NEW YORK, Oct 18 (Reuters) - Abbott Laboratories Inc. (ABT.N: Quote,
> Profile, Research) on Monday said its arthritis drug, Humira, proved
[quoted text clipped - 3 lines]
> it would use the new data to seek approval from U.S. and European regulators
> to treat psoriatic arthritis by the end of this year.
Yippee!

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