Etelcalcetide, also known as Parsabiv, is an intravenous treatment for secondary hyperparathyroidism in patients with chronic kidney disease, according to the report.
Thousand Oaks, Calif.-based Amgen gained rights to the drug through its $315 million acquisition of KAI Pharmaceuticals in July 2012.
While Amgen did not provide specific reasons why the FDA did not approve its drug application, the drugmaker said it plans to meet with the agency to discuss the decision later this year.
More articles on supply chain:
Supply chain tip of the week: How to engage physicians in the decision-making process
EpiPens no longer free for South Carolina’s largest school district
Hillary Clinton calls on Mylan to lower EpiPen prices
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
