Roxadustat CKD Doubts Fanned By FibroGen Data Blunder
Focus Moves To 15 July Cardio-Renal FDA Adcomm
Executive Summary
AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.
You may also be interested in...
A Whole New Year For Pharma: Macro Pressures Mount Heading Into Q1 Reporting
First quarter earnings preview: US drug pricing reform, an uncertain regulatory outlook and new focus on M&A are rising challenges that could put the industry's growth at risk.
AstraZeneca/FibroGen’s Roxadustat Comparison To ESAs In Anemia May By Clarified At FDA Advisory Cmte.
Payers would welcome any additional clarity provided by advisory panel review, given the perception, expressed in a recent ICER report, that the evidence is insufficient to determine whether the new drug is safer or more effective than erythropoiesis-stimulating agents.
One To Watch: Ruling On AZ’s First-In-Class Anemia Drug Roxadustat Expected Shortly
AstraZeneca is in pole position to open up the HIF-PH inhibitor market – but GSK has a rival in the wings.