FDA Panel Raises Safety Concerns Over AstraZeneca’s Anticoagulant Reversal Drug Andexxa

Safety Concerns:
The FDA panel has raised safety concerns over AstraZeneca's anticoagulant reversal drug Andexxa, casting doubt on its full approval[2][4][5].

Current Status:
Andexxa was granted accelerated approval in 2018 but faces challenges in securing full FDA approval due to these concerns[4].

Panel's Stance:
FDA experts have expressed lukewarm support for Andexxa, highlighting risks associated with its use[5].

AstraZeneca's Challenge:
AstraZeneca faces significant hurdles in upgrading Andexxa to full approval in the US, primarily due to safety issues flagged by the FDA panel[4][5].

Regulatory Process:
The FDA's decision on full approval will be influenced by the panel's concerns, which could impact the drug's future availability and use[2][4].