Wyeth receives FDA approval letter for Bazedoxifene

Wyeth Pharmaceuticals has received a second approval letter from the US Food and Drug Administration (FDA) for Bazedoxifene relating to its indication in the prevention of postmenopausal osteoporosis.

The FDA issued the letter following the identification of several issues that had not been resolved by Wyeth’s complete response to the first approval letter.

In particular, the regulatory body has asked for further analyses and discussion regarding the incidence of stroke and venous thrombotic events as well as raising queries over data collection practices.

Wyeth is not required to initiate any new studies in support of its application for the selective oestrogen receptor modulator Bazedoxifene; rather the FDA has suggested an end-of-review conference between the pharmaceutical firm and the agency to iron out the remaining issues.

Gary L Stiles, executive vice-president and chief medical officer at Wyeth Pharmaceuticals, indicated that the company looked forward to working with the FDA to resolve the concerns.

“Wyeth is dedicated to identifying therapies for the millions of postmenopausal women who are at risk for increased bone loss,” he stated.

Earlier this month, Elan and Wyeth announced the dosing of the first patient in the phase III clinical study of bapineuzumab (AAB-001) as a treatment for patients with mild to moderate forms of Alzheimer’s disease.