January 2008
Rituximab Improves RA Symptoms
Posted 1/30/08
A Phase III study of rituximab (Rituxan) in patients with moderate to severe rheumatoid arthritis (RA) met its primary endpoint of significantly greater proportion of Rituxan patients achieving an American College of Rheumatology 20-percent response at week 24 compared with placebo. The study evaluated patients who received two infusions of 500 or 1,000 mg of rituximab in combination with a stable dose of methotrexate.
Denosumab Meets Endpoints in Comparison Study With Fosamax
Posted 1/30/08
Data from a one-year study of twice-yearly denosumab showed the drug achieved significantly greater bone mineral density (BMD) gains compared with alendronate (Fosamax). In the study, 1,189 women with postmenopausal osteoporosis received denosumab or weekly alendronate and were followed for one year to assess changes in BMD. The relative magnitude of BMD improvement at the total hip was approximately 40 percent greater in the denosumab than in the alendronate group.
Results of Osteoporosis Trial Published
Posted 1/16/08
Results from a Phase III trial evaluating the efficacy and safety of once-monthly risedronate 150 mg for the treatment of postmenopausal osteoporosis were published in the January issue of Bone.
The two-year, randomized, double-blind, active-control study is being conducted in 1,292 postmenopausal women 50–88 years old. Patients received risedronate 150 mg monthly or 5 mg daily plus calcium and vitamin D.
The primary efficacy objective of the study was to demonstrate non-inferiority of the monthly regimen versus the daily regimen. At 12 months, the mean lumbar spine bone mineral density was 3.54 percent for the monthly regimen and 3.43 percent for the daily regimen.
Osteoporosis Drug Gets Approvable Letter
Posted 1/3/08
The FDA has issued its second approvable letter for bazedoxifene, a selective estrogen receptor modulator for the prevention of postmenopausal osteoporosis. The agency identified several questions regarding issues that were not resolved fully after the first approvable letter. The FDA has requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events and identified certain issues concerning data collection and reporting. An action date for The July 2007 application is set for May.
