The US FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity for Barth Syndrome
Shots:
- The US FDA has received accelerated approval from the US FDA for Forzinity (elamipretide HCl)] to improve muscle strength in pts with Barth syndrome (Wt.≥30 kg or 66 lbs)
- Approval was based on efficacy and safety data from the TAZPOWER trial, which showed improved knee muscle strength
- Forzinity is a mitochondrial cardiolipin binder. It has received multiple FDA designations ODD, FTD, Priority Review, and RPDD as well as ODD status from the EMA. With approval, Stealth also received a Rare Pediatric Disease Priority Review Voucher
Ref: Stealth BioTherapeutics| Image:Stealth BioTherapeutics| Press Release
Related News:- The US FDA Approves Johnson & Johnson’s Inlexzo for BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com