Hotline Archive - Preliminary FDA Approval of Enbrel (etanercept)
September 1998
Enbrel (entanercept) was reviewed and approved by the FDA’s Arthritis Advisory Committee for use in the treatment of active adult rheumatoid arthritis on September 16, 1998. This drug is the first of a new class of biologic response modifiers, known as TNF-receptors.
Tumor necrosis factor (TNF) is a chemical produced by the immune system that stimulates other inflammatory reactions. TNF has been demonstrated to be a critical mediator of joint inflammation and presumably joint destruction. The body has natural inhibitors of TNF that circulate in the blood and prevent TNF from causing inflammation in healthy individuals. Enbrel is, in part, composed of receptors for TNF that bind and inactivate it before further joint inflammation occurs.
In clinical trials, Enbrel significantly decreased joint swelling and improved other physical findings and laboratory abnormalities of inflammation in the vast majority of patients with active RA. The effect of Enbrel on joint x-ray changes is not known; ongoing studies will answer these issues.
At this time, Enbrel is recommended for use alone in patients who have been unsuccessfully treated with other so-called disease modifying anti-rheumatic drugs (DMARDs). Enbrel can be used alone or in combination with methotrexate. It is administered twice weekly by subcutaneous injection. Treatment with Enbrel is associated with a higher incidence of mild injection site reactions compared to placebo. The use of Enbrel is not recommended in women who are pregnant or nursing.
The committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of Enbrel later this fall. If approved, it will still be several months before Enbrel is available in local pharmacies.
September 17, 1998
Nancy Lane, MD
Elliot Rosenstein, MD
Co-editors, ACR Hotline
The Hotline is provided by the American College of Rheumatology Communications and Marketing Committee as an information service to members. This Hotline does not represent a position statement of the College.
