AstraZeneca Addresses Safety Concerns Over Andexxa, Discontinues Opioid Use Disorder Drug

Andexxa Safety Concerns:
AstraZeneca faced scrutiny from the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee over safety concerns related to Andexxa, an anticoagulation reversal drug. The concerns include a twofold increase in thrombosis and thrombosis-related deaths in Andexxa-treated patients compared to usual care[1][2][4].

ANNEXA-I Trial Results:
The ANNEXA-I trial showed that Andexxa could elicit significantly better hemostasis in patients than usual care, but raised questions about whether the benefit outweighs the serious risks, particularly the increased incidence of thrombosis and thrombosis-related deaths[1][2][3].

Regulatory Discussion:
The FDA advisory committee discussed the safety and efficacy of Andexxa without a formal vote, focusing on the drug's benefit/risk profile and the broader implications for the intended patient population[2][4][5].

Discontinuation of AZD4041:
AstraZeneca discontinued a Phase II trial for AZD4041, an investigational opioid use disorder medication, due to potential drug-drug interaction risks that altered the benefit-risk profile in this patient population[2].

Clinical Context:
Physicians highlighted the value of Andexxa in clinical settings, particularly in emergency situations where rapid reversal of anticoagulation is crucial, but also emphasized the need for careful consideration of long-term risks[2][3].