Stealth Granted Pre-NDA Meeting For Elamipretide To Treat Barth Syndrome

(RTTNews) - Biotechnology company Stealth BioTherapeutics Corp (MITO) announced Tuesday its plan to meet with the U.S. Food & Drug Administration (FDA) Division of Cardiology and Nephrology (DCN) to discuss new clinical data that may inform a potential new drug application (NDA) submission for the treatment of Barth Syndrome.

The Company recently requested a Type B pre-NDA meeting to discuss new clinical data on patients treated with elamipretide for over 3.5 years in the open-label extension period of the Phase 2 TAZPOWER study.

In October 2021, the FDA had refused to file the Company's NDA for the treatment of Barth Syndrome.

The Company believes that the new data may support an NDA filing and approval of elamipretide as a treatment for Barth Syndrome.