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Amryt's dystrophic epidermolysis bullosa drug candidate gets orphan drug designation in US
StockMarketWire.com
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Biopharmaceutical company Amryt said the US Food and Drug Administration had granted orphan drug designation for its drug candidate to treat dystrophic epidermolysis bullosa.
The FDA's Office of Orphan Products Development granted orphan drug designation to support the development of medicines for rare diseases, that affect fewer than 200,000 people in the United States.
Orphan drug designation may allow Amryt to be eligible for a seven-year period of US marketing exclusivity upon approval of AP103 and a waiver of the Prescription Drug User Fee Act filing fees.
At 8:00am: (LON:AMYT) Amryt Pharma share price was 0p at 206p
Story provided by StockMarketWire.com
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