The good news for Daiichi Sankyo: Its new anticoagulant drug matched the old standard-issue drug warfarin at preventing stroke and blood clots. And as far as safety goes, edoxaban beat warfarin by a significant stretch. That's an entree into the warfarin-alternative market, expected to grow to $10 billion over the next several years.
Eye drug Eylea and blood thinner Xarelto are pretty good products for any drugmaker to have in its lineup, and Bayer's got them both. Sales of those new stars have been plentiful, and they helped the German company raise earnings 7.7% for the third quarter, the company announced Thursday.
The Institute for Safe Medication Practices has flagged its latest set of side-effect reports to the FDA--and once again, anticoagulant drugs are at the top. Boehringer Ingelheim's Pradaxa, a new-generation pill, and the old standard therapy warfarin together accounted for more than 1,100 of the adverse events reported direcctly to the FDA.
Herewith we bring you our Top 15 Drug Launch Superstars. Some of them will be obvious to anyone who follows the pharma business. They certainly were obvious to us. But choosing the rest was a challenge--one we weren't exactly expecting, based on previous experience. Read the full report >>
German regulators have responded to Der Spiegel 's questions about Xarelto side effects. Answer? The Federal Institute for Drugs and Medical Devices sees no new red flags for patients using the clot-fighting drug developed by Bayer and Johnson & Johnson.
The number of side-effect reports on Bayer's anticoagulant drug Xarelto appears to be increasing, and some doctors are growing wary of using the drug as a standard first-line treatment, the German newspaper Der Speigel reports.
The FDA keeps offering up tough news to Johnson & Johnson for its warfarin replacement, Xarelto. It has twice turned it down for treatment of acute coronary syndrome (ACS), and today the company said it had a complete response letter for use of the bloodthinner to prevent stent thrombosis in patients with ACS.
The U.K.'s cost-effectiveness watchdog gave final clearance to Bayer's anticoagulant drug Xarelto for use in preventing potentially fatal blood clots in the lungs and legs. Meanwhile, Boehringer Ingelheim was filing for European approval for its new-generation anticoagulant, Pradaxa, for similar uses.
Johnson & Johnson executives were touting the company's pipeline yesterday, drawing attention to the 10 new applications it expects to file in the next four years--some with blockbuster potential. But some analysts said what shouldn't be lost in the mix is that it also is planning 25 significant line extensions by 2017.
Johnson & Johnson and Bayer AG are looking on the bright side of things when it comes to Xarelto. They are undertaking new trials they hope will lead to much wider use of the new kind of blood thinner. The announcement comes days after the FDA for the second time rebuffed their bid to get it a coveted approval for treatment of acute coronary syndrome (ACS).