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Mayzent (Siponimod) & Use in Pregnancy

Basic Details
Status
Complete
Last Updated
Thursday, July 31, 2025
Original Posting Date
Health Outcome(s)
use in pregnancy
Purpose
Drug Utilization
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

The U.S. Food and Drug Administration (FDA) conducted this study within the Sentinel System to assess the prevalence of Mayzent (siponimod) exposure among females of childbearing age, both overall and during pregnancy. This evaluation was initiated to investigate the feasibility of continuing two ongoing pregnancy postmarketing requirements (PMRs).

Using data from six Sentinel Distributed Database (SDD) Data Partners with mother-infant linkage capabilities, spanning April 15, 2019, to July 31, 2024, the study identified 772 females of childbearing age who were exposed to siponimod and met the baseline enrollment requirements. This represented 0.16 patients per 10,000 eligible members and accounted for 43.7% of the 1,766 total female siponimod users across all age groups. Among 3,626,656 pregnancy episodes recorded during the study period, fewer than 11 were exposed to siponimod.

These findings supported the FDA’s decision to release PMRs 3591-4 and 3591-5 and instead require a descriptive pregnancy safety study as a new PMR.

Result(s) (2)
Siponimod Use Among Female Patients: A Descriptive Analysis Siponimod Use During Pregnancy: A Descriptive Analysis