Is Pfizer and Bristol-Myers Squibb's Eliquis really safer than its competitors? A recent analysis of FDA adverse events reports suggested that it is.
Drugmakers should clean out their data closets and turn over to regulators every bit of research and analysis they have, according to some healthcare experts, who point to documents released in litigation against Boehringer Ingelheim, with the company's blockbuster anticoagulant Pradaxa as prime evidence.
Pradaxa has become a bigger legal headache for Boehringer Ingelheim. The German drugmaker says it's facing more than 2,000 lawsuits in the U.S., filed by patients claiming the anticoagulant drug caused severe or fatal bleeding.
Recently unsealed company documents that are part of litigation over the bleeding risks of Boehringer Ingelheim's blockbuster blood thinner Pradaxa show that officials wanted to soften, or even kill, an internal report that suggested a small group of patients would benefit from regular blood monitoring for bleeding risks, The New York Times reports.
FDA and clinical reviews have not found the chances of bleeding to be any greater for Boehringer Ingelheim's Pradaxa than for warfarin, but it continues to top the list for adverse reaction reports, and the FDA has decided to do another data dive into how the two compare.
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.
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.
Every drugmaker dreams of developing a drug so important that it shakes up an entire market. And it happens--just think of Johnson & Johnson's Zytiga, the prostate cancer drug that has not only grown by leaps and bounds, but arguably nudged aside Dendreon's competing treatment, Provenge. Want new examples? That's what Motley Fool offers today.
Boehringer Ingelheim's drugs Pradaxa and Trajenta are both facing obstacles, but sales of both are still growing--and revenues for the company are growing right along with them.
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.