Earlier Reported, Everest Medicines' Partner Calliditas Therapeutics Announces US FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon
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Calliditas Therapeutics (CALT) announced that the U.S. FDA has granted a seven-year orphan drug exclusivity for Nefecon, expiring in December 2030, for a new indication to reduce kidney function loss in adults with primary IgAN.
March 12, 2024 | 7:15 am
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Calliditas Therapeutics received a seven-year orphan drug exclusivity from the U.S. FDA for Nefecon, aimed at treating adults with primary IgAN.
The FDA's grant of a seven-year orphan drug exclusivity for Nefecon significantly enhances Calliditas Therapeutics' competitive position in the market for treatments targeting primary IgAN. This exclusivity until December 2030 secures Calliditas a temporary monopoly on the treatment, potentially leading to increased sales and market penetration. The approval for a new indication also highlights the drug's efficacy and safety, likely boosting investor confidence and potentially leading to a short-term increase in CALT's stock price.
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