Wyeth To Re-Submit Viviant This Year, Expects FDA Advisory Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Merged Pfizer/Wyeth will likely have to choose between Viviant and Fablyn.
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Wyeth plans to submit a "complete response" filing for its osteoporosis drug Viviant this year - and, given the drug's safety concerns, the firm is expecting an FDA advisory committee review to follow. Viviant (bazedoxifene) has received two "approvable" letters since the firm's initial NDA submission, but Wyeth is "pleased" with the drug's clinical profile, execs said during a presentation at the Cowen & Company Health Care Conference March 17. "From Phase III data on bazedoxifene, we've shown so far the [venous thrombotic event] profile is very consistent with what you see with raloxifene [Lilly's Evista ], so that's why we think it should not represent an issue in terms of a final regulatory review," VP Investor Relations Justin Victoria said. FDA requested more information on the incidence of stroke and VTE in an approvable letter for Viviant last May for treatment of postmenopausal osteoporosis - similar to information requested in a 2007 approvable letter for prevention of postmenopausal osteoporosis. The firm initially expected to file a complete response for Viviant by the end of 2008 (1 (Also see "Wyeth’s Viviant “Approvable” For Osteoporosis" - Pink Sheet, 23 May, 2008.)). Wyeth also expects an approval decision for Viviant in Europe "shortly," after it received a positive opinion there. But if Viviant is on the bench awaiting its next move, Wyeth's Aprela, which combines bazedoxifene with conjugated estrogens, is even farther from the playing field. A regulatory filing for Aprela - for vasomotor symptoms, vaginal atrophy and prevention of osteoporosis - has been repeatedly pushed back (2 (Also see "Wyeth Pushes Back NDA Filing Timeline For Aprela For Vasomotor Symptoms" - Pink Sheet, 5 Oct, 2007.)). Wyeth now expects to file for Aprela with a low dosing in early 2010 in the U.S. The firm is still working on bioequivalence and various formulations of the drug. "We're doing additional work with the higher dose right now, but currently the plan is to file for the lower dose initially and then add the higher dose subsequently," Victoria said, padding any additional delays with the caveat that "plans tend to change over time." One Might Have To Go ... Viviant, though, may get the boot given the recent Pfizer merger deal. Selective estrogen receptor modulators are one area where Wyeth and Pfizer have competing projects. Pfizer has Fablyn (lasofoxifene) under review for treatment of osteoporosis, although that agent has received two "not approvable" letters. Still, Pfizer may be apt to keep Fablyn since long-term data released last fall offer means of competitive distinction from Evista (3 (Also see "Pfizer Ready For Fablyn Vs. Evista Match, But FDA May Not Play Along" - Pink Sheet, 22 Sep, 2008.), p. 11). Safety is a concern for Fablyn too. Pfizer and partner Ligand received a "complete response" letter from FDA in January for the selective estrogen receptor agent, citing an apparent increase in mortality among patients using the drug (4 'The Pink Sheet,' Jan. 26, 2009, In Brief). - Carlene Olsen ([email protected]) |