FDA clear Bayer and JnJ’s blood clot treatment
The FDA has cleared Bayer and Johnson & Johnson’s anticoagulant Xarelto for use in hospitalised, acutely ill medical patients at risk of serious blood clots.
The approval came as a result of data from the MAGELLAN and MARINER trials of Xarelto (rivaroxaban), which showed that the drug could be safely used to prevent venous thromboembolism (VTE) in hospitalised patients who weren’t at high risk of bleeding.
The new indication gives Xarelto the advantage over other drugs in the novel oral anticoagulant (NOAC) class, which include Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban), Boehringer Ingelheim’s Pradaxa (dabigatran), Daiichi Sankyo’s Savaysa (edoxaban) and Portola’s Bevyxxa (betrixaban).
The approval also gives doctors the first oral alternative to daily injections with older anticoagulants such as warfarin and heparin for patients with acute medical illnesses, which have been the standard treatment for decades.
NOACs such as Xarelto have quickly gained ground as an alternative to older injectables because the latter can require regular testing to make sure the anticoagulant effect stays within the desired therapeutic range and are more likely to result in bleeding episodes.
The new approval means Xarelto can be started for these patients during their time in hospital and continued after discharge for a total duration of 31 to 39 days, according to J&J’s Janssen Pharma division.
Current US guidelines recommend that acutely ill medical patients at risk for VTE receive anticoagulants – typically injectable agents – while in hospital but advise against routine use after they are discharged.
The new indication could go some way towards reinvigorating Xarelto, which was the first NOAC to reach the market and led the class for several years. Latter it has seen its position eroded by its rivals, particularly Eliquis, which according to IQVIA data reported earlier this year is the market leader with a share of around 39% versus 23% for Bayer/J&J’s drug.