Xarelto is the anticoagulant pill from J&J and Bayer. It was supposed to be a major blockbuster and compete with Pradaxa from Boehringer Ingelheim. Now analysts are saying that it might end up as a third line treatment behind warfarin and Pradaxa, if it even gets approval. The FDA is looking for more safety as well as more efficacy data in the prevention of stroke among Afib patients. Ouch. I think this is a big hurt for Bayer.
The market seemed surprised as the FDA seemed more upbeat about the product back in July.
Lovenox, which was the branded gold standard, is off patent this year so new products were highly anticipated. Coumadin/warfarin has been used for decades but it has bleeding, stop/start and food interference issues.
Having three drugs so close together in approval (Pradaxa, Xarelto and apixaban) was actually amazing since no new drugs have been approved since Lovenox.
Now, we did a review of anticoagulation back in October 2010. So looking back at the study, we did see evidence that cardiologists were critical of Xarelto's data and were worried about liver and non-major bleeding problems in their Afib patients. So I guess I am less surprised than others on this one.
At the time, we reported being less than enthusiastic with the data ourselves. I really am not a big fan of warfarin, mostly because physicians like to put patients on it for life and it restricts them so much in terms of having an active life. But is has been used for decades so anything replacing it really needs to be more safe and more effective, IMHO.
Wool Labs is working to develop Phase IV/V programs to look at safety and efficacy of products through the lens of how patients report performance and experience. We already work with clients as well as publish our own research on how patients discuss their diseases and conditions, medication, and safety and efficacy measures. So the point to this blog is to explore this concept further.
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