Arena Finds Antidote For Belviq’s Theoretical Risk Of Valvulopathy In Mechanistic Studies
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Additional preclinical studies provided FDA with reassurance during a second-cycle review that lorcaserin was unlikely to trigger the valvular heart disease associated with dexfenfluramine and fenfluramine.
You may also be interested in...
When Opportunity Knocks: Eisai Turns To Business Development
Starting in 2006, Eisai embarked on a bold campaign to reorient the company around cancer – with an emphasis on externally sourced innovation – that put aggressive business development front and center. Now as Eisai prepares to launch what may be its most transformative in-licensed product, the weight-loss therapy Belviq, signs of trouble have appeared in its trophy cancer franchise.
Regulatory Round-Up: Drug Review Profiles From 2012
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. If you do not have access, contact customer care at 1-800-332-2181 for a free copy of any of these articles.
Regulatory Round-Up: Drug Review Profiles From 2012
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.