July 2008
New Biologic for RA Nears Approval
Posted 7/29/08
The Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended approval of tocilizumab (Acetemra), an interleukin-6 (IL-6) receptor-inhibiting biologic therapy, for the treatment of moderate to severe rheumatoid arthritis (RA) in adults. The committee's vote was made after results from five Phase III clinical trials were presented. Of these five studies, three trials were conducted in patients with inadequate response to disease modifying anti-rheumatic drugs (DMARDs); one trial was conducted in patients who failed anti-tumor necrosis factor (TNF) therapy; and one study compared tocilizumab to methotrexate, a current standard of care. Results of these studies demonstrated that treatment with tocilizumab -- alone or in combination with methotrexate or other DMARDs -- significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with current DMARDs.
"It's always good to have new options for treating patients, but with a new drug, you don't know what the side-effect profile is," said Dr. Patience White, chief public health officer at the Arthritis Foundation. "In RA, you have a nearly 100 percent chance of being totally disabled and dying early, and you have a small chance of the side effects we're talking about."
Gout Drug in Phase II
Posted 7/17/08
Regulatory approval has been granted to begin a Phase IIa proof-of-concept clinical trial evaluating RDEA806 in gout patients with hyperuricemia. The randomized, double-blind, dose-ranging, efficacy and safety trial will be conducted at medical centers in Europe and Canada. To establish normal serum uric acid (sUA) concentrations in gout patients with hyperuricemia, the trial will compare the sUA level of two dose regimens of the drug with placebo.
