Alirocumab: Phase III ongoing

Both Sanofi and Regeneron disclosed in SEC filings that FDA has become aware of neurocognitive adverse events in the PCSK9 inhibitor class and that the agency requested the partners assess potential events in the development program for alirocumab. Additionally, the partners said FDA requested to be informed about the feasibility of incorporating neurocognitive testing into at least a subset of patients in the ongoing Phase III ODYSSEY OUTCOMES trial or other long-term Phase III trials.

FDA declined to provide details, including the compound or compounds that caused the adverse events and whether the events occurred for PCSK9 monotherapy or in combination with statins. The labels for statins contain warning language about the risk of neurocognitive adverse events. Sanofi said the partners are not aware of a neurocognitive signal for alirocumab. ...