FDA approves first at-home therapy for thyroid eye disease

The first at-home subcutaneous treatment for thyroid eye disease met its primary end point in 1 of 2 phase 3 trials.

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The FDA approved satralizumab-mwge (Enspryng) for adults with thyroid eye disease, making it the first approved at-home subcutaneous treatment for the condition.
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Patients or trained caregivers can administer satralizumab-mwge, with injections at weeks 0, 2, and 4 followed by maintenance dosing every 4 weeks.
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In SatraGO-2, proptosis response at week 24 occurred in 52.9% of satralizumab-treated patients and 23.4% of placebo recipients; the trial met its primary end point.
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SatraGO-1 did not meet its primary end point; proptosis response occurred in 49.0% of satralizumab-treated patients and 31.2% of placebo recipients.
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Prescribing information calls for screening for hepatitis B and tuberculosis and monitoring for infection, elevated liver enzymes, and reduced neutrophil counts.

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