Wyeth’s Viviant “Approvable” For Osteoporosis
This article was originally published in The Pink Sheet Daily
Analysis sought for treatment indication is similar to what FDA requested for prevention setting.
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FDA cleared the single pill combining conjugated estrogens with bazedoxifene, a novel selective estrogen receptor modulator, for two indications but issued a “complete response” letter for use in vulvar and vaginal atrophy.
Conditions associated with menopause represent a huge market, yet the R&D pipeline has long been slim, despite the well-known drawbacks of marketed hormone replacement therapies. But new approaches with a tissue-selective estrogenic effect are emerging: Shionogi’s Osphena for menopause-related sexual dysfunction broke the long drought in NME approvals, and Pfizer’s broad NDA for bazedoxifene/conjugated estrogens is under review. Emerging companies like EndoCeutics are exploring new hormonal approaches.
Merged Pfizer/Wyeth will likely have to choose between Viviant and Fablyn.