Amgen Inc.’s application seeking approval for its drug Parsabiv has been rejected by the U.S. Food and Drug Administration, the company announced Thursday.
Parsabiv treats hyperparathyroidism in adults with chronic kidney disease on hemodialysis. Hyperparathyroidism can develop in response to declining kidney function, creating an excess of hormones, which can lead to other health complications like bone thinning.
The FDA issued a letter turning down the application for Parsabiv, which the Thousand Oaks biotech is currently reviewing.
The company anticipates a meeting with the regulatory agency later this year to discuss the response, which does not affect regulatory submissions in other countries.
Amgen shares closed down 61 cents, or a fraction of a percent, to $170.23 on the Nasdaq.