Sprout's Flibanserin Gets Reluctant Nod From FDA Panel, But REMS Needed
This article was originally published in The Pink Sheet Daily
Advisory committee votes 18-6 to recommend approval of the female sexual dysfunction drug contingent on a risk management plan, despite unease about modest efficacy and risks such as fainting.
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Agency directs Sprout to disseminate corrective messages about the risks associated with the female sexual dysfunction pill. Sprout previously challenged FDA’s alcohol labeling requirements.
In sharp disagreement, FDA says postmarketing trial shows risk of taking alcohol with the female sexual dysfunction drug; Sprout will appeal agency's decision.
BIO Notebook Day 4: Gottlieb Seeks Early Engagement On Gene Therapy; Ireland’s Brexit Opportunities; AMAG’s Bremelanotide Strategy; Alzheimer’s ‘Learnings’
US FDA to head off cell/gene therapy manufacturing issues with pre-IND meetings; Republic of Ireland will “chase any opportunities” for business partners stemming from Brexit, even while hoping UK reconsiders EU departure; AMAG won’t follow the flibanserin PR approach with newly submitted female sexual dysfunction drug bremelanotide; United Neuroscience CMO Ajay Verma says Alzheimer’s trial setbacks are “learnings,” with progress toward novel therapies moving faster than it has for cancer and HIV.