Two European Commission drug approvals announced

The European Commission on Friday approved the first treatment advance for secondary hyperparathyroidism, as well as the first interleukin-12/23 inhibitor licensed for Crohn’s disease.

It has granted marketing authorization for US biotech major Amgen’s (Nasdaq: AMGN) Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week at the end of a hemodialysis session.

"Keeping relevant lab values in recommended target ranges is an important part of managing sHPT, a chronic and complex disease with an already complicated medication regimen for many patients," said John Cunningham, professor of nephrology at University College London Medical School, adding: "Treatment failures are quite common and Parsabiv provides a new tool that should give physicians more confidence that patients are getting the medication they need to treat their sHPT.