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STOCKHOLM The Food and Drug Administration has given orphan drug designation to a treatment for a rare kidney disease under mid-stage clinical development by privately owned Swedish drug maker PharmaLink, the company said.
The FDA granted the designation to Nefecon (PL-56), a treatment for IgA nephropathy, also known as Berger’s disease, a disorder that leads to end-stage kidney disease. The FDA gives orphan drug designation to incentivize development of treatments for rare and serious disorders.
“Today’s news marks a significant milestone for PharmaLink and increases the commercial value of Nefecon as it moves toward the marketplace,” PharmaLink managing director Johan Haggblad said. “We believe this product candidate has great potential in treating IgA nephropathy.”