trending Market Intelligence /marketintelligence/en/news-insights/trending/YtZXaS5SV7KgO0F_mmCq4w2 content esgSubNav
In This List

Portola resubmits US FDA biologics license application for AndexXa

Case Study

Identifying PPE Suppliers During the Pandemic

Blog

Highlighting the Top Regional Aftermarket Research Brokers by Sector Coverage

Video

COVID-19 Impact & Recovery: Healthcare Outlook for H2 2021

Blog

Corporate Credit Risk Trends in Developing Markets: A Loss Given Default (LGD) Perspective


Portola resubmits US FDA biologics license application for AndexXa

Portola Pharmaceuticals Inc. resubmitted its biologics license application for AndexXa, a reversal agent for Factor Xa inhibitors, to the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research.

The resubmission includes supplemental information primarily related to manufacturing, as requested by the FDA in a complete response letter issued to Portola in August 2016.

AndexXa is a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor. The drug has a breakthrough therapy designation from the FDA.