The FDA has issued a complete response letter for Amgen’s NDA for its chronic kidney disease candidate Parsabiv.
Amgen said it is reviewing the response letter and anticipates a meeting with the FDA later this year to discuss it. The company did not disclose why the application was turned down.
The submission was based on data from Phase III studies, one of which showed that 74 percent of the patients given the drug experienced a more than 30 percent reduction in parathyroid gland secretions compared to an 8.3 percent reduction in the placebo arm.
Parsabiv is intended to treat secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease.