California pharmaceutical pioneer Portola Pharmaceuticals announced recently that they have completed the second round of clinical trials for an antidote that could stop bleeding in emergencies for millions of people taking new generation blood thinners.
This is the latest step in a long process towards FDA approval; however, records show thousands of users could benefit immediately.
The development comes as use of three new drugs: Xarelto, Pradaxa and Eliquis have swelled in recent years as patients move away from the blood testing and diet restrictions of stalwart anticoagulant Coumadin.
Trials have shown the three newer drugs may be better at preventing blood clots that plague those with atrial fibrillation and who have undergone surgery. They may also result in fewer instances of internal bleeding. However, when it does strike it can turn deadly.
Coumadin, the trade name for warfarin, is a cumbersome drug with many dangerous side effect risks of its own. However, in situations of severe internal bleeding doctors can give an antidote injection to quickly stop it.
So far, the same isn’t available for Xarelto, Pradaxa and Eliquis.
Portola’s new antidote, Andexanet alfa, has shown promising results in phase I and phase II clinical trials for stopping bleeding for Xarelto and Eliquis. However, it doesn’t work on Pradaxa since that drug has a different chemical make up.
If the company is successful at bringing an antidote to market, it could relieve fears from doctors around the world that are hesitant to recommend the new style drugs.
Records from the FDA and EMA in Europe show over 10,000 patients hospitalized with serious intestinal or brain bleeding from the three new medications, resulting in over 1,000 deaths.
Pradaxa maker Boehringer Ingelheim recently paid $650 million to settle thousands of injury claims, while cases against Johnson & Johnson/Bayer over Xarelto bleeding are growing just as fast this year.
The dangers haven’t prevented sales of the new drugs from skyrocketing. Xarelto sales grew 68% in the 3rd quarter of 2014 to $414 million, and are expected to eclipse $2 billion annually in coming years with new uses set for approval.
And, with an antidote on the horizon serving to allay some fears, experts say the anticoagulant market could hit $3 billion.
Stay tuned for more information on anticoagulant research from DrugNews.
Sources:
Portola Press Release. Phase 3 ANNEXA(TM)-A Study of Andexanet Alfa and Eliquis (Apixaban) Met Primary and Secondary Endpoints With High Statistical Significance. (October 1, 2014). Retrieved from: http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=1972736
Seeking Alpha. Portola's New Factor Xa Antidote Could Help Drive Xarelto And Eliquis Sales. (October 9, 2014). Retrieved from: http://seekingalpha.com/article/2550955-portolas-new-factor-xa-antidote-could-help-drive-xarelto-and-eliquis-sales
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