Hemostasis Today
NewsFeed
Headlines Hematology Health Medicine VTE ASH Plasma Donation
March, 2026
March 2026
M T W T F S S
 1
2345678
9101112131415
16171819202122
23242526272829
3031  
Niraj Sharma: Andexxa – Now Voluntarily Withdrawn From the U.S. Market
Niraj Sharma/LinkedIn
Dec 31, 2025, 08:31

Niraj Sharma: Andexxa – Now Voluntarily Withdrawn From the U.S. Market

Niraj Sharma, Cardiac Electrophysiologist/Cardiologist at Northside Hospital, shared on LinkedIn:

“EP Edge | BREAKING NEWS
Just when we thought reversal was the solution…
Andexxa (andexanet alfa) — the first-in-class reversal agent for factor Xa inhibitors (apixaban, rivaroxaban) — has now been voluntarily withdrawn from the U.S. market, with U.S. sales ending December 22, 2025

WHAT CHANGED?
The decision follows FDA review of post-marketing safety data and results from the ANNEXA-I confirmatory randomized trial, required after Andexxa’s 2018 accelerated approval.
Bottom line from the FDA:
The risks now outweigh the benefits.

KEY SAFETY SIGNALS (ANNEXA-I)
Compared with usual care, patients receiving Andexxa had:
Higher thrombotic events:
14.6% vs 6.9%
Higher thrombotic-related deaths at 30 days:
2.5% vs 0.9%
Earlier thrombotic events:
53% of Andexxa-treated patients had earlier events vs 6.3% with usual care
Importantly, Andexxa already carried a boxed warning, but these findings confirmed a clinically meaningful safety signal, not just a theoretical risk

A REGULATORY LESSON
Accelerated approval was based on anti-FXa activity reduction (a surrogate endpoint)
The required outcomes trial failed to confirm net clinical benefit
This is exactly why post-approval trials matter

WHY THIS MATTERS TO PRACTICE
This is not just about one drug.

  •  Loss of the only specific Xa reversal agent in the U.S.
  •  Forces re-evaluation of DOAC bleeding protocols
  •  Reinforces caution with surrogate endpoints
  •  Highlights the need for safer reversal strategies

EP EDGE TAKEAWAY
Innovation is essential —
but safety must survive real-world evidence.
As clinicians, we owe our patients both speed and certainty.”

Niraj Sharma: Andexxa - Now Voluntarily Withdrawn From the U.S. Market

Get insights from Hemostasis Today.

Anticoagulation Breaking News clinical trials Electrophysiology FDA Headlines Health Hemostasis Hemostasis Today Medicine Niraj Sharma Real World Evidence thrombosis
NewsFeed