Amgen has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the marketing authorization of Parsabiv (etelcalcetide) for treating secondary hyperparathyroidism in adult patients with chronic kidney disease  on hemodialysis. If approved, Parsabiv, a calcimimetic agent, can be administered intravenously by a healthcare provider three times a week at the end of a hemodialysis session.

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization with unified labeling will be granted in the 28 countries that are members of the EU. Norway, Iceland, and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.

In the US, Amgen received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) in August 2016 for Parsabiv. Amgen is reviewing the CRL and anticipates a post-action meeting with the FDA later this year to discuss it.

Source: Amgen