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.
You may also be interested in...
Russell Katz will retire following a 30-year career at FDA; his departure comes as the agency is embarking on new efforts to encourage drug development for Alzheimer’s disease and amyotrophic lateral sclerosis.
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.
Nearly one-third of clinical trial patients taking the antiepileptic had to stop due to adverse events.