FDA’s Sentinel Likely To Outpace Traditional Post-Market Studies, But Will It Replace Them?

A Mini-Sentinel study examining the potential risk of acute myocardial infarction and/or stroke attributable to overactive balder drug Myrbetriq (mirabegron) should be complete before Astellas Pharma Inc.’s own post-market cardiovascular outcomes study – leaving questions about how the results may affect the firm’s study and how the Sentinel program might alter sponsor post-marketing obligations more broadly.

So far FDA has not provided much detail on how Sentinel, its soon-to-be-fully-enacted active pharmacovigilance system, will impact other post-marketing safety monitoring programs, but it seems logical that the outcome...