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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

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