Anthera completes special protocol assessment with FDA and receives EMEA scientific advice on development path toward varespladib approval
Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA’s Special Protocol Assessment procedure. At the same time, the company received Scientific Advice from the European Medicines Agency (EMEA) on Anthera’s European development strategy for varespladib. Guidance from both regulatory agencies regarding varespladib will be incorporated into Anthera’s global registration program slated to start next year.
© 2020 Pappas Capital, LLC. ALL RIGHTS RESERVED.