No Comparison: Viibryd’s Path Of Least Resistance Through FDA Could Mean Rocky Marketing
This article was originally published in Pharmaceutical Approvals Monthly
FDA’s statutory neutrality on comparative effectiveness in drug approval decisions both helped and held back Viibryd (vilazodone), now owned by Forest Laboratories. Because approval requires only that a candidate proves superiority to placebo, not to any existing treatments, the antidepressant entered a highly competitive, crowded market with statistically significant but commercially unremarkable efficacy.
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Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.
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Although a significant portion of the U.S. population – approximately 6.5% or 15 million adults annually – suffers from depression, the antidepressant drug market is on the decline and sales are expected to decrease further over the next two years as two of the largest products on the market, Forest Laboratories’ Lexapro (escitalopram) and Eli Lilly & Co.’s Cymbalta (duloxetine), face patent expirations.