Using the Sentinel System in FDA Submissions

Recently, FDA has been using RWD from Sentinel System (SS) in drug approval process quite often to evaluate some safety signals in the postmarket setting and also for other purpose.

For past three advisory committee meetings hold in January 2019, SS has been applied in two approval processes (Jan 11 and Jan 17 , 2019) and one (Jan 16, 2019) in proposing potential possibility to use SS database in post-marketing safety study.

In the first advisory committee meeting (Jan 11, 2019), FDA employed Sentinel System to analyze and compare gout population with CARES population to evaluate risk of adverse CV events (MACE) of Febuxostat and to examine if patients in the CARES trial truly reflect gout patients in real world settings. The data used in Sentinel System were from Sentinel Distributed Database (SDD) from Jan 1, 2009 to Sept 30, 2016 with 17 health plans over 122 million enrollees.

In Jan 16th, 2019 meeting for the drug Romosozumab, a drug for treatment of osteoporosis in postmenopausal women at high risk of fracture, FDA proposed several real world data (RWD) for after approval postmarketing safety study, including SDD and patient registries to evaluate the cardiovascular effect of Romosozumab and generalizability of safety results from the trial.

The third meeting, hold on Jan 17th, was for Sotagliflozin, an adjunct to insulin in adult patients with type 1 diabetes. In this approval process, FDA explored DKA risk associated with SGLT2 inhibitors among T1DM patients through post-marketing data from FDA Adverse Event Reporting System (FAERS) database. From which, a one-day search in September 11-12, 2018 for all FDA-approved SGLT2 inhibitor products retrieved 6714 reports.

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