Wyeth's bazedoxifene receives third "appro" letter, as Relistor misses Ph III endpoint

US drug major Wyeth's osteoporosis drug candidate bazedoxifene received a third "approvable" letter in the same week that a second drug candidate, Relistor (methylnaltrexone bromide) injection, missed its primary endpoint in a late-stage post-operative ileus study.

The Food and Drug Administration issued an approvable letter on May 21 for Wyeth's selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis, requesting information similar to that outlined in its second letter issued in December 2007. This included further analyses concerning the incidence of stroke and venous thrombotic events. The agency also identified specific questions concerning data collection and reporting, and requested additional source documents.

"Today's action is in line with our expectations," said Gary Stiles, chief medical officer of Wyeth Pharmaceuticals. "In our conference with the agency earlier this year, they stated their desire to convene an advisory committee to review the pending New Drug Applications for both treatment and prevention of postmenopausal osteoporosis," he noted.