Wyeth Pharmaceuticals, a US major, has reported promising results for bazedoxifene from a placebo-controlled Phase 3 study. The drug, a selective estrogen receptor modulator (SERM), is under clinical investigation for the prevention and treatment of postmenopausal osteoporosis.
The trial of bazedoxifene 20 mg indicated a significant reduction in new vertebral fractures in postmenopausal women with osteoporosis, the company said in a press release.
The results were from a two-year extension of a three-year Phase 3 trial, which enrolled 7,492 generally healthy postmenopausal women aged 55 to 85 years with osteoporosis.
At five years, the study showed that the incidence of new vertebral fractures was significantly reduced in the bazedoxifene 20 mg group (4.5%) and in the group transitioned from bazedoxifene 40 mg to 20 mg (3.9%) compared with placebo (6.8%).
These and other data were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Denver, Colorado.
"These new data are important in that they suggest the reduction in vertebral fracture risk with bazedoxifene seen at five years is comparable to that seen at three years," says Stuart Silverman, Clinical Professor of Medicine at the University of California, Los Angeles and Cedars-Sinai Medical Center, and the study's lead investigator.
But Wyeth has had trouble getting the drug approved in the U.S. In May, it received, for the third time, a letter from the FDA delaying an approval decision. The FDA wanted further analysis about the rate of stroke and other events related to blood clots, and also had some questions about data collection.
Wyeth expects to file a response by year end to the FDA's latest letter. The drug was approved in Europe and will be launched "on a country-by-country basis as appropriate" beginning in 2010, according to a Wyeth spokesman.
Pfizer has also suffered approval delays with its osteoporosis drug Fablyn, which was twice rejected before the company announced in January that the FDA was delaying its decision to approve the drug until it got more information about a possible increase in deaths, according to Bloomberg.
Next month, the FDA is expected to make a decision on Amgen's denosumab, which came out of a recent FDA advisory committee meeting with mixed reviews. The FDA said clinical-trial patients taking denosumab had a slightly elevated rate of serious infections and certain cancers than patients who received a placebo, but the difference wasn't statistically significant, Shirley S. Wang writes in Wall Street Journal.