FDA has issued a second "approvable" letter for Wyeth's Viviant (bazedoxifene) for prevention of postmenopausal osteoporosis, this time requesting further data on stroke and venous thrombotic events.

In the letter, the agency "requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events" and "also identified certain issues concerning data collection and reporting and requested additional source documents," Wyeth said Dec. 24.

Wyeth had submitted clinical study reports from recently completed trials in Asia in November and mid-December, but the agency did not review them, the firm noted (¹ Also see "Wyeth Submits More Viviant Data To FDA" - Pink Sheet, 17 December, 2007.).

However, "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."

In the latest approvable letter, FDA also "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."

In April, the company received an approvable letter from FDA seeking fracture data from a three-year pivotal trial and evaluation of Wyeth's Guayama, Puerto Rico, manufacturing facility (² Also see "Wyeth’s Viviant “Approvable” For Prevention Of Postmenopausal Osteoporosis" - Pink Sheet, 24 April, 2007.).

Wyeth pointed out that FDA will not require any additional studies. The agency "has suggested an end-of-review conference between Wyeth and the FDA to address the remaining issues," the company said.

The firm submitted a separate NDA in July seeking approval of Viviant for the treatment of postmenopausal osteoporosis. That application has a May 2008 user fee date

-Brooke McManus (b.mcmanus@elsevier.com)

Wyeth’s Viviant Receives Second “Approvable” Letter For Osteoporosis Prevention

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