FDA Approves Wyeth's Bazedoxifene For Prevention Of Postmenopausal Osteoporosis
FDA has issued a second approvable letter for Wyeth Pharmaceuticals' bazedoxifene, a selective estrogen receptor modulator, for the prevention of postmenopausal osteoporosis.
In its letter, the FDA identified several remaining questions regarding issues that had been previously identified during the review process and that were not fully resolved by the Company's complete response to the first approvable letter. The FDA has requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events. The Agency also identified certain issues concerning data collection and reporting and requested additional source documents.
The FDA stated that the Wyeth Asian studies that were submitted on November 9 and December 14, 2007, were not reviewed for this action. Wyeth believes the data from these nearly 1,000 women provide additional support for a favorable benefit to risk ratio for bazedoxifene in the prevention of postmenopausal osteoporosis.
The Agency did not request the initiation of any new studies and has suggested an end-of-review conference between Wyeth and the FDA to address the remaining issues.
"We look forward to working with the FDA to resolve these issues. Wyeth is dedicated to identifying therapies for the millions of postmenopausal women who are at risk for increased bone loss," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals.
The Company received the first approvable letter on April 23, 2007, and submitted data requested in June 2007. In July 2007, Wyeth submitted a separate New Drug Application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis, which was accepted for filing in September 2007, with an action date in May 2008.