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 (Germany)
Disease:
- • treatment of pulmonary embolism and prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism
- • 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 November 20, 2012, Bayer HealthCare’s oral anticoagulant Xarelto® (rivaroxaban) has been approved by the European Commission (EC) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. This approval makes rivaroxaban the only novel oral anticoagulant approved in this indication in the EU.The approval of rivaroxaban for the treatment of PE and the prevention of recurrent DVT and PE in adults is based on the important clinical findings from the pivotal, global Phase III EINSTEIN-PE study. With 4,833 patients enrolled, EINSTEIN-PE is the largest study ever conducted in the acute treatment of PE. The study compared the oral single-drug solution of rivaroxaban 15 mg twice daily for three weeks, followed by 20 mg once daily, with the current dual drug approach of subcutaneous enoxaparin followed by a VKA. Patients were treated for three, six or 12 months.
- • On November 2, 2012 , Bayer has announced that the FDA has approved the oral anticoagulant Xarelto® (rivaroxaban) for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE. Rivaroxaban was approved by the FDA on a priority review timeline, making it the only novel oral anticoagulant approved and the first oral single-drug solution proven effective for the treatment of DVT and PE in the U.S.
Rivaroxaban is approved to treat patients with DVT or PE at a dose of 15 mg twice daily for three weeks, followed by 20 mg once daily for the remaining treatment period. Rivaroxaban is also approved to reduce the risk of recurrent episodes of DVT and PE at a dose of 20 mg once daily following an initial six months of treatment for acute venous thromboembolism.
The approval of rivaroxaban for these new uses was based on data from the global EINSTEIN program, which included three Phase III studies that demonstrated the efficacy and safety profile of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the long-term prevention of recurrent DVT and PE in these patients.
- • On July 9, 2012, Bayer and Janssen Research & Development have announced that the FDA has granted Priority Review to the supplemental New Drug Applications (sNDAs) filed on May 2, 2012 for Xarelto® (rivaroxaban) to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and to prevent recurrent DVT and PE.
- • On May 2, 2012, Bayer announced that its cooperation partner, Janssen Research & Development has submitted supplemental New Drug Applications (sNDAs) to the FDA seeking approval for the use of Xarelto® to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and to prevent recurrent venous thromboembolism (VTE). The submissions are supported by data from the global EINSTEIN program, which included almost 10,000 patients. The three Phase III studies evaluated the safety and efficacy of rivaroxaban in the treatment of DVT and PE and the prevention of recurrent VTE. Results from these three studies have been published in the New England Journal of Medicine (10.156/NEJMoa1113572 and 10.1056/NEJMoa1007903).
- • On April 12, 2012, Bayer HealthCare has announced that it has submitted an application for marketing authorization to the European Medicines Agency (EMA) for the oral anticoagulant Xarelto® (rivaroxaban) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. The submission is supported by data from the pivotal, global Phase III EINSTEIN-PE study, the results of which were presented at the American College of Cardiology’s 61st Annual Scientific Session (ACC) in March this year and were published simultaneously by the New England Journal of Medicine (10.156/NEJMoa1113572). Rivaroxaban demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic VTE, a composite of symptomatic deep vein thrombosis (DVT) and non-fatal or fatal PE. The overall bleeding rates were similar between the treatment groups, but importantly rivaroxaban was associated with significantly lower rates of major bleeding.
Patents:
Submission of marketing authorization application USA : 2012-05-02
Submission of marketing authorization application UE: 2012-04-12
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2012-11-02
UE authorization: 2012-11-20
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
