FDA Approves Weekly Enbrel
Injection Can Be Given Once a Week
Oct. 22, 2003 -- The FDA has approved the rheumatoid arthritis drug Enbrel for once-weekly dosing.
Before now, Enbrel was only recommended as two 25 milligram injections three or four days apart. Now the 50 milligram dose can be given the same day.
Amgen Inc. and Wyeth Pharmaceuticals jointly produce Enbrel. Both companies are WebMD sponsors.
This new approval affects people with moderate-to-severe rheumatoid arthritis, psoriatric arthritis, and ankylosing spondylitis. The drug is also approved for once-a-week use in children between 4 to 17 years old with moderate-to-severe juvenile rheumatoid arthritis.
Enbrel is a genetically made protein that is delivered by injection and works by binding to a naturally occurring protein in the body called tumor necrosis factor (TNF), which is involved in the inflammatory process that triggers the pain and swelling of the joints associated with rheumatoid arthritis. Basis for Approval
In studies, the once-weekly dosage was shown to be as safe and effective as the twice-weekly dosing in 420 patients with rheumatoid arthritis.
After eight and 16 weeks of treatment, there were no significant differences in the improvement of arthritis symptoms. Patients tolerated the once-weekly dosage just as well as the twice-weekly dosing.
Enbrel was first approved nearly five years ago.
SOURCE: News release, Wyeth Pharmaceuticals.