AZP-3601 Earns FDA’s Orphan Drug Designation

AZP-3601 Earns FDA’s Orphan Drug Designation

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AZP-3601 Earns FDA’s Orphan Drug Designation

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AZP-3601, an investigational therapy for hypoparathyroidism by Amolyt Pharma. The designation is given to treatment candidates with the potential to be safe and effective in rare diseases, defined in the U.S as those affecting fewer than 200,000 people. It is meant to expedite AZP-3601’s clinical development by providing regulatory support and financial benefits, as well as a seven-year marketing exclusivity period in the U.S.…

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