Chart: Class-Wide REMS For Anti-Epileptics Remains A Work In Progress
Executive Summary
The epilepsy market seems poised to change with the entry of a new product following a positive advisory committee for GlaxoSmithKline/Valeant's Potiga (ezogabine), and a swift approval could be aided by an already-prepared Risk Evaluation and Mitigation Strategy (see preceding story). The risk management of many approved epilepsy products is changing as well, as sponsors implement class-wide warning of increased risk of suicidality to their products' labeling and develop a REMS including a Medication Guide. FDA issued its letter to sponsors requiring the changes Dec. 16, 2008 ("The Pink Sheet," Jan. 5, 2009), but 20 months after the safety changes were mandated, only half of the products have added a REMS. The pace of implementation is noteworthy because the 2007 legislation that FDA invoked in mandating the changes was designed to give the agency the power to swiftly make safety-related labeling changes. Getting sponsors to adopt REMS has proved more complicated.
You may also be interested in...
Additional Risks Of I.V. Anticonvulsants To Be Taken Up By FDA Panel
A joint advisory committee will determine if regulatory action is necessary to reduce risks from intravenous administration of phenytoin and fosphenytoin, including the risk of a skin disease that can lead to amputation.
Class Labeling For Anti-epileptics Embraces Lessons From Antidepressants
Anti-epileptic drug sponsors have until mid-January to decide whether to fight FDA-mandated labeling changes and a REMS program after a meta-analysis showed a statistically significant increase in suicidality.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011