Gilenia Advisory Committee: Is REMS + Phase IV > FDA Safety Concerns?
This article was originally published in The Pink Sheet Daily
Executive Summary
Novartis' oral multiple sclerosis drug Gilenia (fingolimod) faces an unusually large briefing package from FDA focused on safety concerns.
You may also be interested in...
Novartis Gilenya Approved With Advisory Panel-Enhanced REMS
FDA follows the advice of its Peripheral and Central Nervous System Drugs Advisory Committee to ask doctors to do a range of testing and monitoring when they prescribe the MS drug.
Novartis Gilenya Approved With Advisory Panel-Enhanced REMS
FDA follows the advice of its Peripheral and Central Nervous System Drugs Advisory Committee to ask doctors to do a range of testing and monitoring when they prescribe the MS drug.
Gilenia's Risk Management Should Key On Initial Doctor Visit, Cmte. Says
Novartis' Risk Evaluation and Mitigation Strategy for Gilenia (fingolimod) may need to include more explicit testing requirements instead of just the physician and patient education programs that the firm has proposed