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Calliditas Therapeutics Says Kidney Disease Drug Granted Seven-Year Exclusivity Period by FDA
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Calliditas Therapeutics Says Kidney Disease Drug Granted Seven-Year Exclusivity Period by FDA
Mar 6, 2024 1:07 AM

03:42 AM EST, 03/06/2024 (MT Newswires) -- Calliditas Therapeutics ( CALT ) said Wednesday the US Food and Drug Administration has granted its kidney disease drug Tarpeyo an orphan drug exclusivity period of seven years, expiring in December 2030 based on when the company received full approval with a new indication for the product.

Tarpeyo is indicated "to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy who are at risk for disease progression," the company said.

The exclusivity period reflects the new indication for all adult patients with primary immunoglobulin A nephropathy at risk of disease progression.

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