Novartis Withdraws Zioxtenzo Application

Novartis and Sandoz have withdrawn their application for Zioxtenzo (pegfilgrastim) from the European Medicines Agency. The Neulasta biosimilar was being developed to treat low levels of white blood cells in cancer patients.

The sponsors withdrew the application based on study results that were not able to demonstrate that blood concentrations of pegfilgrastim were the same after taking Zioxtenzo compared to Neulasta.

Additionally, the manufacturing site for the drug lacked a GMP certificate, meaning an inspection of the site will have to be performed before the drug can be approved. The medication had been accepted for FDA review last year, but received a CRL a few months later.