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International

Atrophic AMD drug put on the fast track for approval

05/03/2019
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The US Food and Drug Administration (FDA) has put a treatment for atrophic age-related macular degeneration (AMD) and Leber’s hereditary optic neuropathy on the fast track for approval.

The drug, elamipretide, is being developed by Massachusetts-based Stealth BioTherapeutics and CEO Ms Reenie McCarthy said she was pleased the FDA had recognised its potential to treat the disease.

The FDA’s fast-track process is designed to speed up the approval process for new drugs that treat serious conditions and fill unmet medical need. Drugs given the designation are provided more frequent communication with the FDA, alongside a rolling submission process.

The next stage for the drug’s development will be a randomised, double-masked, placebo controlled clinical study to determine the safety and effectiveness of subcutaneous injections of elamipretide for patients suffering geographic atrophy.

As well as geographic atrophy, elamipretide has also been granted fast-track approval for the treatment of primary mitochondrial myopathy, Barth syndrome and three rare primary mitochondrial diseases.

AFT Pharmaceuticals
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