The eighth indication in the United States! Bayer / Johnson xarelto approved for prevention of VTE

Bayer and Johnson's Janssen Pharmaceutical recently announced that the US FDA has approved xarlto (rivaroxaban) as an anticoagulant for the prevention of venous thromboembolism (VTE) in hospitalized patients with acute medical diseases at risk of thromboembolic complications but without high risk of bleeding With the approval of this new indication, xarelto treatment can be started for these patients during hospitalization and continued after discharge The total recommended duration is 31-39 days Acute medical disease is a broad term used to describe serious but common medical diseases These patients had an increased risk of thromboembolism within three months of discharge, with 80% of the events occurring within the first six weeks Although VTE is largely preventable, current guidelines only recommend anticoagulants (usually injection drugs) to prevent VTE in patients with acute medical diseases at risk of VTE during hospitalization, and do not recommend routine anticoagulant treatment after discharge Studies have shown that many patients refuse to use injectable anticoagulants because of fear, discomfort, anxiety or inconvenience Prevention of thrombosis is an important priority for doctors in the treatment of patients with acute medical diseases With this approval, xarelto will provide an oral treatment alternative to daily anticoagulant injections to help prevent thromboembolism during hospitalization and after discharge, which may change the management of long-term thromboprophylaxis in such patients in hospitals and after discharge A number of phase III clinical studies conducted in this high-risk group of patients have shown that xarelto at a dose of 10mg is an effective and safe choice to help prevent thrombosis More than 20000 patients were enrolled in the phase III clinical project to evaluate xarlto for patients with acute medical diseases, including two phase III clinical studies, Magellan and mariner Magellan evaluated the use of xarlto in the prevention of VTE in hospitalized patients with acute medical disease and limited mobility The study reached two common primary efficacy endpoints: short-term use of xarlto (10 ± 4 days) showed non inferiority compared with low-molecular-weight heparin enoxaparin, long-term use (35 ± 4 days) showed superiority compared with short-term use of enoxaparin + subsequent placebo treatment In this study, the incidence of major and non major clinically related bleeding was higher in the xarlto treatment group Magellan study an important post-mortem analysis found that by applying five additional exclusion criteria to exclude patients with high blood risk due to active gastroduodenal ulcer, recent bleeding, active cancer, history of severe bronchiectasis or pulmonary cavity, and dual antiplatelet therapy at baseline, the researchers determined the beneficial benefit risk of xarelto prevention of VTE The mariner study, based on the results of the Magellan study, was conducted in a population of similar patients with acute medical disease, comparing xarelto and placebo in the prevention of VTE and VTE related deaths after discharge The results showed that although xarelto did not reduce the composite end point of VTE and VTE related deaths compared with placebo, it significantly reduced symptomatic VTE and had consistent and good safety Xarlto: xarlto, the drug with the most approved indications, was developed jointly by Bayer and Johnson & Johnson It is the most widely used non vitamin K antagonist oral anticoagulant (noac) in the world At present, it has been approved with 9 indications, which are different in different countries Compared with other noac, xarelto can help a wide range of patient groups to prevent a variety of VTE and arterial thromboembolism diseases In the United States, xarelto has been approved for 8 indications, which is the most approved one among the direct oral anticoagulant drugs Six of them are specially used for the treatment, prevention and reduction of VTE recurrence risk in a wide range of people Xarelto was listed in 2008 and was once the market leader of warfarin alternative drugs, but its status has now been replaced by eliquis, an anticoagulant from Pfizer and BMS, which was listed in 2011 In recent years, with potential safety advantages and effective marketing strategies, the market share has expanded rapidly In 2018, the sales volume of xarelto exceeded that of xarelto for the first time, becoming the best-selling Saban anticoagulant Some analysts pointed out that expanding the label is expected to help reverse the decline in xarlto sales Some analysts also pointed out that it will be a challenge for xarelto to stand up At present, eliquis is growing rapidly The drug not only dominates the warfarin alternative drug market, but actually has replaced warfarin as the most commonly prescribed anticoagulant In the second quarter of this year, eliquis's global sales reached $2 billion, and data from the real world further pressured competitors In September, data released by Pfizer and BMS showed that the bleeding rate of eliquis was lower than that of standard nursing vitamin K antagonists, xarlto and pradaxa, an anticoagulant from Boehringer Ingelheim Global data forecasts that eliquis will become the second-largest selling drug in 2025, with sales of US $18.7 billion, second only to keysruda, which is expected to reach US $22.5 billion in 2025 Reference sources: 1 U.S FDA approvals xareto? (rivaroxaban) to help prevent blood closures in effectively ill medical patients 2 U.S FDA approvals rivaroxaban to help prevent blood closures in effectively ill medical patients 3 J & J, Bayer's xarlto scores FDA nod to treat acute ill patients during and after hospitalisation 4 Bayer's 2018 financial report: stable growth of rivaroxaban and abexipu this article is the content reprinted by drug intelligence The copyright belongs to the original author The purpose of reprinting is to transmit more information and does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.