This article is part of the Arthritis Archives.
Dateline: December 31, 2002
FDA Approves Humira
Humira (adalimumab) was approved by the United States Food and Drug Administration on December 31, 2002. As an investigational drug Humira was known as D2E7.
Humira (generic name adalimumab), was 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 rheumatoid arthritis patients were the basis for the approval.
The efficacy of Humira was assessed by evaluating improvement in the rheumatoid arthritis signs and symptoms response score and inhibition of the progression of structural damage in rheumatoid arthritis as measured by bone changes in x-rays. 22% (14/63 patients) experienced improvement in rheumatoid arthritis 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.
Other Anti-TNF Drugs
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.
Sources: Press Release: Abbott Laboratories Receives FDA Approval Earlier Than Anticipated For Humira (adalimumab) For The Treatment Of Rheumatoid Arthritis, December 31, 2002: FDA Approves Rheumatoid Arthritis Option, AP, December 31, 2002
First published: 12/31/2002