FDA Approves HUMIRA

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FDA Approves HUMIRA

Abbott's first human monoclonal antibody approved to treat rheumatoid

arthritis.

The United States Food and Drug Administration approved HUMIRA (adalimumab)

on December 31, 2002. As an investigational drug HUMIRA was known as D2E7.

HUMIRA, developed by Abbott Laboratories as part of a scientific

collaboration with Cambridge Antibody, is the first human monoclonal

antibody approved for reducing the signs and symptoms and inhibiting the

progression of structural damage in adults with moderately to severely

active rheumatoid arthritis who have had an insufficient or inadequate

response to one or more disease-modifying anti-rheumatic drugs (DMARDs).

HUMIRA was created using phage display technology.

The approval of HUMIRA, which comes earlier than expected, is an exciting

development for rheumatoid arthritis patients. HUMIRA offers convenience as

an every other week subcutaneous injection. A specially designed pre-filled

syringe will be available, making the self-injection process easier for

rheumatoid arthritis patients whose hands have been destroyed or deformed by

the disease. The easy-to-use design of the syringe earned the Arthritis

Foundation Ease Of Use Commendation Seal.

HUMIRA is approved to be used alone or in combination with methotrexate. It

works by blocking TNF-alpha, a protein that plays a significant role in the

inflammatory pathway of autoimmune diseases. Results from 4 controlled

clinical trials in more than 2000 RA patients were the basis for the

approval. The efficacy of HUMIRA was assessed by evaluating improvement in

the RA signs and symptoms response score and inhibition of the progression

of structural damage in RA as measured by bone changes in x-rays. 22%

(14/63 patients) experienced improvement in RA signs and symptoms as early

as one week. ACR responses have been noted in patients after three years.

The FDA approval comes nine months after regulatory submissions were

simultaneously submitted to the U.S. FDA and the EMEA (European Agency for

the Evaluation of Medicinal Products). The EMEA is expected to approve

HUMIRA in mid-2003.

HUMIRA will compete with other anti-TNF drugs, Enbrel and Remicade. Enbrel

is self-administered twice weekly and Remicade is an infusion given in a

doctors office. The first shipments of HUMIRA in the U.S. will begin the

first week of January 2003 with nationwide sales by the end of January. The

wholesale price will match that of Enbrel at around $1,100/month. For more

information and updates on HUMIRA, including full prescribing information,

go to http://www.abbottimmunology.com or http://www.HUMIRA.com

Other features about HUMIRA (adalimumab)

REFERENCE:

PRESS RELEASE: ABBOTT LABORATORIES RECEIVES FDA APPROVAL EARLIER THAN

ANTICIPATED FOR HUMIRA (ADALIMUMAB) FOR THE TREATMENT OF RHEUMATOID

ARTHRITIS (RA), DECEMBER 31, 2002

FDA APPROVES RHEUMATOID ARTHRITIS OPTION, AP, DECEMBER 31, 2002

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