Viibryd Dose Selection Was Weak Spot, But Sponsor’s Gamble Paid Off
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
“The inadequacy of dose exploration is clearly the ‘Achilles heel’ of this application,” Office of Drug Evaluation I Deputy Director Ellis Unger declared in his Jan. 21, 2011, decision memo for the approval of Clinical Data, Inc.’s antidepressant Viibryd (vilazodone).
You may also be interested in...
Review Of Reviews: Drug Review Profiles Of 2011
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.
No Comparison: Viibryd’s Path Of Least Resistance Through FDA Could Mean Rocky Marketing
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.
No Comparison: Viibryd’s Path Of Least Resistance Through FDA Could Mean Rocky Marketing
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.