Bayer and Johnson & Johnson have plunked down hundreds of millions to study the anticoagulant Xarelto for one use after another. Armed with more indications than any of its warfarin-alternative rivals, Xarelto now has the biggest share of that market.
What's long been a three-horse race just gained a fourth horse with the FDA's green light for Daiichi Sankyo's clot-fighter Savaysa. With the FDA's Thursday blessing, the drug will now face down a new-age anticoagulant trifecta that's been duking it out in the marketplace for a while now.
Bayer and Johnson & Johnson are fighting a consolidation of lawsuits over their top-selling anticoagulant Xarelto, months after patients filed suit in the U.S. accusing the companies of downplaying the drug's risks.
These days, sometimes it's not enough to prove your drug is more effective than the standard of care. As rising drug costs continue to trigger concerns and pushback among payers, providers and patients, it's not a bad idea to prove your drug can beat the old guard on cost--or at the very least, match it. And that's just what Johnson & Johnson's Janssen unit says it's done with Xarelto.
Bayer's Xarelto, which has been cruising along since it joined a new class of warfarin replacement therapies on the market, has faced a rare stumbling block in acute coronary syndrome--an indication the FDA has denied it on three separate occasions. But across the pond, it's picked up a nod in some ACS patients from the U.K.'s cost-effectiveness gatekeeper.
Johnson & Johnson's Janssen unit is recalling 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination.
Johnson & Johnson is riding the tailwinds of recent success, celebrating positive third quarter earnings buoyed by record-setting sales of its top products and the sell-off of its Ortho-Clinical Diagnostics business.
Johnson & Johnson and Bayer's Xarelto already heads up the pack of new-age anticoagulants, but the pair isn't quitting while it's ahead. Instead, the drugmakers are looking to expand that market lead with new clinical trials aimed at widening the drug's label.
The inevitable has happened for Bayer's fast-selling anticoagulant blockbuster, Xarelto. Someone in the U.S. has filed a lawsuit over its safety concerns. In fact, a number of lawsuits have been filed, according to reports in a German newspaper.
It turns out that Boehringer Ingelheim's popular anticoagulant Pradaxa is safer than many people think. That is the finding of the FDA after taking another look at the side effects of the drug compared to the old standard warfarin and this time looking at a much larger and older patient base.