Elamipretide: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Elamipretide. Educational only — not medical advice.
Labeled uses
FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Source: FDA labeling via NIH DailyMed (set 146bf34c…). Not affiliated with FDA or NIH.
Medical disclaimer: Always consult a qualified healthcare professional about any medication.