This article is part of the Arthritis Archives.
Dateline: December 24, 2002
Meeting The Demand For EnbrelOn December 23, 2002, Amgen announced more exciting news for people who are on or are candidates for Enbrel (etanercept). The U.S. Food and Drug Administration (FDA) has approved the Rhode Island manufacturing facility. With the approval, a significant supply of Enbrel is now available for patients. Production had been underway at the Rhode Island facility for months. More than 550 highly skilled professionals monitor the production of Enbrel and perform hundreds of controls and validation studies throughout the process to ensure its quality. The facility, which houses eight 8,000 liter bioreactors (tightly-controlled vessels needed to produce large quantities of Enbrel through recombinant DNA technology), is a 250,000 square foot structure.
Application For Once-Weekly Dosing
Amgen has a supplemental Biologics License Application (sBLA) with the FDA supporting once-weekly dosing of Enbrel. Results from a Phase III study revealed that patients treated with 50 mg Enbrel once-weekly achieved similar efficacy, tolerability, and pharmacokinetics (the characteristic interactions of a drug and the body in terms of its absorption, distribution, metabolism, and excretion) when compared to patients receiving 25 mg of Enbrel twice-weekly.
Enbrel acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins which play a key role in both normal immune function and the cascade of reactions associated with the inflammatory process. As Enbrel binds to TNF, it renders it biologically inactive, resulting in significantly reduced inflammatory activity.
Enbrel is used to:
- Treat the signs and symptoms of active arthritis in psoriatic arthritis.
- Reduce the signs and symptoms and inhibit structural damage in patients with moderately to severely active rheumatoid arthritis.
- Treat newly diagnosed juvenile rheumatoid arthritis patients.
- Reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to DMARDs (disease-modifying anti-rheumatic drugs).
Sources: FDA Approves Enbrel Manufacturing Facility, Supply For Patients Dramatically Increases, Press Release, 12/23/02;
Amgen Submits Data To FDA Supporting Once-Weekly Dosing of Enbrel, Press Release, 12/23/02
First published: 12/24/2002