On Monday, Novartis reported that results of a clinical study on patients with osteoporosis who suffered a hip fracture show that a once-yearly infusion of its Reclast reduced the risk of subsequent fractures by 35%, compared with patients treated with a placebo. The results of this phase 3 study were published in The New England Journal of Medicine. In August, Reclast was approved as the first and only once-yearly treatment for postmenopausal osteoporosis.
Not to be outdone was Wyeth, which presented phase 3 clinical data for bazedoxifene on Wednesday at the annual meeting of the American Society for Bone and Mineral Research. In a three-year study, data showed that bazedoxifene significantly reduced the risk of new vertebral fractures by about 40% when compared with a placebo.
Wyeth has already received an approvable letter about its pending New Drug Application (NDA) for bazedoxifene for preventing postmenopausal osteoporosis. In July, the drugmaker submitted a separate NDA to the Food and Drug Administration for bazedoxifene for the treatment of postmenopausal osteoporosis.
Fosamax is set to go off-patent in February, so Novartis, Wyeth, and Eli Lilly
The two studies released this week by Novartis and Wyeth provide additional promising alternatives to Fosamax, but the companies have a tough road ahead in this market.