Elamipretide Hydrochloride
Drug Details
- Generic Name
- Elamipretide Hydrochloride
- Brand Names
- FORZINITY
- Application Number
- NDA215244
- Sponsor
- Stealth Biotherapeutics Inc.
- NDC Codes
- 1
- Dosage Forms
- INJECTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- ELAMIPRETIDE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE 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. FORZINITY™ is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. ( 1 ) This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint. ( 14 ) Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).