MedPath

AZD-4041

Generic Name
AZD-4041

AstraZeneca Faces Safety Concerns Over Andexxa, Halts Opioid Use Disorder Drug Trial

• An FDA advisory committee reviewed AstraZeneca's application for full approval of Andexxa, raising concerns about increased thrombosis risk compared to standard care. • Panelists debated the applicability of ANNEXA-I trial data to the broader patient population, questioning the overall benefit/risk profile of Andexxa. • AstraZeneca discontinued a Phase II trial of AZD4041 for opioid use disorder due to potential drug-drug interactions altering the benefit-risk assessment.
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