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IMAAVY™

(nipocalimab-aahu)

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IMAAVY™ (nipocalimab-aahu)
Medical Information

IMAAVY - Overview of the PETUNIA Pregnancy Safety Study

Last Updated: 07/22/2026

Summary

  • The company cannot recommend any practices, procedures, or usage of IMAAVY that deviate from the approved labeling.
  • The Pregnancy Enhanced Tracking with Neonatal and Infant Assessment (PETUNIA) study is being conducted to evaluate the prevalence of pregnancy outcomes, maternal complications, and neonatal and infant health outcomes following exposure to IMAAVY immediately before or during pregnancy through the collection and analysis of prospective and retrospective reports.1 

CLINICAL DATA

PETUNIA

PETUNIA is a global, noninterventional, single-arm study that is being conducted in a postmarketing setting to estimate the prevalence of pregnancy outcomes, maternal complications, and neonatal and infant health outcomes after exposure to IMAAVY immediately before or during pregnancy, using prospective and retrospective reports.1

Study Design/Methods

  • Patients with documented exposure to ≥1 dose of IMAAVY at any time immediately before (≤2 weeks before the last menstrual period [LMP]) or during pregnancy were included (see Figure: PETUNIA Study Design).

PETUNIA Study Design1

Abbreviations: LMP, last menstrual period.
aPregnancy reports will be defined as prospective or retrospective based on the timing relative to the pregnancy and testing performed before the initial report and will vary based on study objective.


Key Variables to be Collected in the Targeted Follow-up Questionnaires1
Baseline
Pregnancy outcome
Neonatal and infant outcomes
Maternal information
Pregnancy course, including pregnancy- and MG-related complications
Infant status and medical history, including history of vaccination
Information on current pregnancy, including prenatal testing
MG disease activity during pregnancy
Admission to neonatal intensive care unit
Medication and other substance exposure during current pregnancy
Medication and other substance exposure during current pregnancy
Outcomes including MCMa and serious infection
Maternal history, including obstetric history, MG status, and medical history (including comorbidities)
Pregnancy outcome
Maternal status and MG disease course, and medication exposure during lactation
Paternal history
Postnatal growth deficiency
Delayed neurodevelopment
Abbreviations: MCM, major congenital malformation; MG, myasthenia gravis.
aCongenital abnormality requiring medical or surgical treatment, resulting in a serious adverse effect on health and development, or having a significant cosmetic impact.

Primary and Secondary Endpoints in the PETUNIA Study1
Objective
Endpoints
Primary Endpoint
To estimate the prevalence of maternal complications and fetal and neonatal outcomes among patients following exposure to IMAAVY during pregnancy
  • Restriction of fetal growth
  • Hypertensive disorders of pregnancy, including pre-eclampsia, gestational hypertension, eclampsia, and HELLP syndrome
  • Placental abruption
  • Small for gestational age
To estimate the prevalence of neonatal and infant serious infections among patients following exposure to IMAAVY during pregnancy
  • Serious neonatal infection (0-27 days)
  • Serious infections during the first year of life
To estimate the prevalence of nonchromosomal MCMa in pregnancies of patients following exposure to IMAAVY during pregnancy
  • Nonchromosomal MCMa
Secondary Endpoint
To estimate the prevalence of other pregnancy, neonatal, and infant outcomes among patients following exposure to IMAAVY during pregnancy
  • Live birth
  • Spontaneous abortion
  • Stillbirth
  • Postpartum hemorrhage
  • Intrapartum hemorrhage
  • Preterm birth
  • Neonatal death
  • Infant death
Abbreviations: HELLP, hemolysis, elevated liver enzymes, and low platelets; MCM, major congenital malformation.
aCongenital abnormality requiring medical or surgical treatment, resulting in a serious adverse effect on health and development, or having a significant cosmetic impact.
Data Analysis
  • The estimated sample size is ≥162 pregnancies with 50 prospectively reported cases with known outcomes, over a 10-year period from regions where IMAAVY is approved and prescribed.
  • Analyses will be stratified by prospective and retrospective reports, with prospectively reported constituting the primary analysis.
    • To minimize selection bias, retrospective reports are evaluated separately in a secondary analysis.
    • Prospective and retrospective case classifications are defined per study objective based on when outcomes become clinically apparent.
  • The proportion of IMAAVY-exposed pregnancies, mothers, and neonates or infants will be determined for each endpoint, with 95% confidence intervals, using exact methods.
  • Prevalence estimates will be assessed based on prevalence in the overall generalized myasthenia gravis (gMG) population and the general pregnant population.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 18 June 2026.

 

References

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1 Goyal N, Robinson CJ, Schneider-Gold C, et al. Pregnancy enhanced tracking with neonatal and infant assessment (PETUNIA): design of a safety study for nipocalimab in generalized myasthenia gravis. Poster presented at: The 12th Congress of the European Academy of Neurology (EAN); June 27–30, 2026; Geneva, Switzerland.  

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