FDA Accelerated Approval to Stealth Bio’s FORZINITY™ for Barth Syndrome: First-Ever Therapy for Ultra-Rare Mitochondrial Disease

Stealth BioTherapeutics Inc. (Stealth Bio), a clinical-stage biotech innovator specializing in mitochondrial medicine, has announced a major regulatory milestone: the U.S. Food and Drug Administration (FDA) has granted accelerated approval for FORZINITY™ (elamipretide HCl). This novel therapy is now authorized to improve muscle strength in both adult and pediatric patients diagnosed with Barth syndrome, provided they weigh at least 30 kilograms (66 pounds).

Thelansis’s “Barth Syndrome Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2024 To 2034” covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Barth Syndrome treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).