Pharmalink AB has been granted orphan drug designation by the US Food and Drug Administration (FDA) for Nefecon, its lead product candidate for the treatment of patients with IgA nephropathy, also known as Berger’s Disease.
Nefecon is an oral small molecule product that works by down regulating the inflammatory process in the kidneys, and is being co-developed by Pharmalink and Archimedes Pharma.
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The drug has demonstrated positive results in the interim analysis of an ongoing Phase II trial, which is designed to evaluate its efficacy and safety.
The FDA’s orphan drug designation is granted to drugs that treat rare diseases affecting less than 200,000 people in the US.
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