Date: 2017-09-14
Type of information: Granting of a Market Authorisation in the EU
Product name: Xarelto®
Compound: rivaroxaban
Therapeutic area: Cardiovascular diseases
Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor
Company: Bayer Healthcare (Germany)
Disease:
- • prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) following an acute DVT in adults
- • extended prevention of recurrent venous thromboembolism
Latest news:
- • On September 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion to update the label for Xarelto® (rivaroxaban) to include a 10 mg once daily dose for the extended prevention of recurrent venous thromboembolism (VTE). This label update will apply to patients who have already received at least six months of standard anticoagulation therapy. Once approved, this will provide physicians with an additional treatment option alongside the 20 mg once daily dose already licensed in this indication. The final European Commission decision is expected by November 2017.
- The positive CHMP opinion is based on data from the Phase III EINSTEIN CHOICE study, which showed that both 10 mg and 20 mg once daily dosages of rivaroxaban significantly reduced the risk of recurrent VTE compared with aspirin 100 mg once daily (acetylsalicylic acid) in patients who had previously completed 6 to 12 months of anticoagulation therapy for treatment of pulmonary embolism and / or symptomatic deep vein thrombosis. All three treatment groups showed comparable and low rates of major bleeding (the principle safety outcome). Data from EINSTEIN CHOICE were published in The New England Journal of Medicine in March 2017.
- • On May 28, 2014, Bayer HealthCare’s oral anticoagulant Xarelto™ (rivaroxaban) has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for marketing authorization to treat patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as to prevent recurrent venous thromboembolism (VTE). The submission to the MHLW is based on the results of three global clinical trials within the pivotal EINSTEIN Clinical Trial Programme, and is supported by the J-EINSTEIN studies (J-EINSTEIN DVT and J-EINSTEIN PE), which were run entirely in Japan. The EINSTEIN DVT and EINSTEIN PE studies evaluated rivaroxaban alone versus the dual-drug regimen of low molecular weight heparin (LMWH) and a vitamin K antagonist (VKA) in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) respectively, and in the prevention of recurrent DVT and PE. The EINSTEIN Extension study compared rivaroxaban with placebo for the long term prevention of recurrent symptomatic DVT and PE in patients who previously completed 6 or 12 months of anticoagulation treatment with either VKA or rivaroxaban. Pooled data of over 8,000 patients reaffirmed that the single-drug approach with Xarelto is effective in both the treatment and subsequent prevention of recurrent DVT and PE, with an overall safety profile comparable to the traditional dual-drug regimen. In addition, compared to the traditional dual-drug approach of injectable LMWH followed by a VKA, Xarelto significantly reduced the rate of major bleeding events by 46 per cent, including the risk of fatal bleeding, whilst offering an improved benefit-risk profile regardless of patient age, frailty, gender, weight or renal function. Results from the three global studies have been published in the New England Journal of Medicine (10.156/NEJMoa1113572 and 10.1056/NEJMoa1007903). Results of the J-EINSTEIN studies are planned to be presented at an upcoming scientific meeting.
- • On September 23, 2011, Xarelto® (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for both the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF), as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2011-12-19/2017-10-19
Favourable opinion UE: 2011-09-23/2017-09-14
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
