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Moderna's metabolic disorder drug granted expedited US FDA review

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Moderna's metabolic disorder drug granted expedited US FDA review

Moderna Inc. has received the U.S. Food and Drug Administration's fast track designation for its rare metabolic disorder drug.

The fast track designation accelerates the review of therapies and vaccines for serious conditions. Drug programs with the fast track tag may benefit from early and frequent communication with the FDA as well as a rolling submission of the marketing application.

The U.S. regulator awarded the fast track designation for the company's investigational drug mRNA-3927 for the treatment of propionic acidemia, a rare inherited metabolic disorder characterized by the deficiency of an enzyme involved in the digestion of certain proteins. Moderna said in an Oct. 22 press release that the disease has no currently approved treatments for its underlying cause.

Cambridge, Mass.-based Moderna plans to start a phase 1/2 study of the drug to treat primarily pediatric patients with propionic acidemia in the U.S. and Europe.

Moderna's mRNA-3927 therapy was previously granted the orphan drug and rare pediatric disease designations from the FDA and orphan designation by the European Medicines Agency.