Wyeth's novel selective estrogen receptor modulator Viviant (bazedoxifene) is "approvable" for prevention of postmenopausal osteoporosis, the firm announced April 24.

Two key remaining elements in the regulatory process are the submission of fracture data from the pivotal program and evaluation of the Viviant manufacturing facilities. The drug is one of several pending Wyeth compounds manufactured at the firm's Guayama, Puerto Rico, facility.

"FDA must receive and analyze, as part of its benefit-risk assessment, final safety and efficacy data from the recently completed Phase 3 treatment study of bazedoxifene," Wyeth said in a statement.

Regarding manufacturing, the company said, "FDA must complete an acceptable establishment evaluation for the manufacturing and testing facilities for bazedoxifene."

The decision does not come as a surprise as Wyeth alerted investors during its first-quarter earnings call that a delay was anticipated due primarily to a need to review the forthcoming fracture data (¹ Also see "Wyeth Says Fracture Data Review Will Delay Viviant Launch" - Pink Sheet, 19 April, 2007.).

"We will work closely with the FDA to address the items noted in the letter and are moving forward with plans to seek an additional indication for the treatment of postmenopausal osteoporosis for bazedoxifene later this year," the firm added. Wyeth indicated during the Q1 call that the treatment submission could occur shortly after the mid-2007 response to the approvable letter.

- Lee Szilagyi (l.szilagyi@elsevier.com)

Wyeth’s Viviant “Approvable” For Prevention Of Postmenopausal Osteoporosis

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