The US Food and Drug Administration (FDA) has delayed its decision on Stealth BioTherapeutics’ new drug application (NDA) for elamipretide, a treatment for the ultra-rare disease Barth syndrome.

The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.

The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.

If approved, this would be the first marketing authorization for elamipretide, a first-in-class mitochondria-targeted therapeutic, and the first FDA-approved therapy for Barth syndrome.

Also appointed were former Minister for Power, Prof. Barth Nnaji, as Vice President, and Prof. Jerry Chidozie Chukwuokolo as Secretary until full elections are held to fill other vacant positions.

A senior at Academy of Notre Dame, Katie Barth is a Global Citizen Scholar candidate, a Blue and Gold Key Society member, and active member of Mock Trial and Model UN clubs and started Academy of ...

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