Marc Stone, MD

FDA recently approved Lybalvi for the treatment of schizophrenia and for use in manic and mixed (depressive and manic) episodes of bipolar I disorder as an acute treatment, a maintenance treatment, and for use with valproate or lithium.

The FDA can require a safety program called a Risk Evaluation and Mitigation Strategy, or REMS, for a medication with serious safety concerns to ensure the benefits outweigh the risks. An REMS is designed to reinforce behaviors and actions that support safe use of that medication to mitigate a specific risk.