"Ernie - I believe the approval is not limited to outpatient only."
My bad, I just assumed they would get the indication that was defined by Mariner. They got the whole enchilada. FDA let them use an exploratory analysis from Magellan to exclude likely bleeders and narrow the indication. My apologies to Ulingt, you made a good point. Maybe this will renew some interest in B. When you compare Magellan to Apex, B clearly looks better than X. The press release is below.
U.S. FDA Approves XARELTO® (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients
XARELTO® provides a new oral option to help prevent venous thromboembolism (VTE) and VTE-related death during hospitalization and post-hospital discharge in acutely ill medical patients at risk for VTE and not at high risk of bleeding
Despite being largely preventable, VTE, or blood clots, remains a significant risk for millions of Americans hospitalized with an acute medical illness
RARITAN, N.J., October 14, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved XARELTO® (rivaroxaban) for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding. With the approval of this new indication, XARELTO® can be initiated for these patients during hospitalization and continued after discharge for a total recommended duration of 31 to 39 days. To date, the FDA has granted XARELTO® eight indications – the most of any direct oral anticoagulant (DOAC) – six of which are
specifically for the treatment, prevention and reduction in the risk of recurrence of VTE across a wide range of patient populations.
Click to Tweet: New oral treatment option now approved to help prevent #bloodclots #VTE in adults hospitalized for an acute medical illness, providing an alternative to injectable anticoagulants, which have long been the standard of care https://ctt.ec/UOp3r+
“With this new approval, XARELTO® as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, M.D., Professor of Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health at Lenox Hill Hospital, New York, NY.1 “The Phase 3 clinical studies in this high-risk patient group show us that XARELTO® at the 10mg dose is an effective and safe option to help prevent blood clots.”
More than seven million Americans are hospitalized each year with an acute medical illness, which is a broad term used to describe serious, yet common, medical conditions.i These patients are at increased risk of blood clots for up to three months after hospital discharge, with 80 percent of events happening within the first six weeks.ii,iii In response to the burden of VTE in hospitalized patients, the Surgeon General issued a Call to Action in 2008 for key stakeholders to build a coordinated plan that could lead to a reduction in VTE across the U.S.iv However, a recent study found that in-hospital VTE rates continue to rise and more work is needed to reduce the burden of VTE especially among those at lower risk.v
Guidelines currently recommend that acutely ill medical patients at risk of VTE receive anticoagulants, typically injectable agents, in the hospital to protect them from blood clots, but advise against routine anticoagulant use after leaving the
Research shows that many patients refuse treatment with injectable anticoagulants out of fear, discomfort, anxiety or inconvenience.
“Preventing blood clots is a critical priority for physicians treating patients with acute medical illnesses, which is why Janssen is pleased that the FDA approved the use of XARELTO® to address this often fatal, yet preventable condition,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. “Rather than facing daily injections with older anticoagulants, patients now have a new oral treatment option that will help prevent blood clots, both in the hospital and after hospital discharge.”
About the Phase 3 Clinical Program More than 20,000 patients with acute medical illnesses were evaluated in the Phase 3 clinical programix,x, which includes the MAGELLAN and MARINER studies. Published in 2013, MAGELLAN evaluated the use of XARELTO® in preventing VTE in hospitalized patients with an acute medical illness and restricted mobility, starting with their hospital stay and continuing through post-hospital discharge. The study met its two co-primary efficacy endpoints, with XARELTO® demonstrating noninferiority to enoxaparin, a low-molecular-weight heparin (LMWH), in short-term use (10 ± 4 days) and superiority in long-term use (35 ± 4 days) compared to short-term use of enoxaparin followed by placebo. The combined rates of major and non-major clinically relevant bleeding were higher in the XARELTO® group.
An important post-hoc analysis from MAGELLAN found that, by applying five additional exclusionary criteria to remove patients at high risk for bleeding due to active gastroduodenal ulcer, recent bleeding, active cancer, history of severe bronchiectasis or pulmonary cavitation, or dual antiplatelet therapy at baseline, researchers established a favorable benefit-risk profile for VTE prevention with XARELTO®.
Additionally, building on the foundation from MAGELLAN, the Phase 3 MARINER trial was conducted in a similar population of acutely ill medical patients. Published in
2018, MARINER evaluated XARELTO® for the prevention of VTE and VTE-related death following hospital discharge compared to placebo. While XARELTO® did not reduce the composite endpoint of VTE and VTE-related death, it did significantly reduce symptomatic VTE with consistent and favorable safety, reinforcing the positive benefit-risk profile of XARELTO®.