Exanta

[Hans]

Hi, I think most of you already know about Exanta, but I will pass on this information anyway. Exanta is an new drug that we hope in the near future will replace Warfarin (Coumadin). Exanta does not have the side effects as the other does(as far as we know now).
There will be studies here in sweden on valve patients in the near future (near future for scientists is as we know a relative word) and lets hope this study will be as good as the ones they have done on other types of prosthesis and related diseases.


All the best from Stockholm
Tick on.......

 

[Nancy]

Hi Hans-

Please keep us up to date on that drug. We've been watching for trials on valves for a long time. This is the first we've heard about them coming up, I think. So we'll all be waiting to hear. Thanks.

 

[Guest]

I thought that I put something about that on here back in October. Anyhow, back Then I had dinner with the US product manager for Exanta. He said that they were just starting to test it on valves implanted in sheep.

They did not actually put the valve in the sheep's heart because that would be more difficult than what they did. Instead they put the valve in the aorta. Then they rerouted the blood in the sheep's body so that the blood all goes through the kidney first. The idea being that if any clots form, they will get caught in the kidney blood vessels. That way they do not have to look all over the whole body seeking small clots. The estimate was that it would be about 5 years before they have all of the data and get it approved by the FDA.

One interesting sidelight. They have presented data to the FDA about the effectiveness of Exanta in preventing blood clots in the legs after surgery. When they designed the study they planned to compare Exanta with warfarin managed by physicians. When they did the study, they compared Exanta with warfarin managed by anticoagulation clinics. The clinics have a much lower rate of warfarin complications. As a result they could only show equivalence, not superiority to warfarin. The FDA wants the statistics to show that there was a less than 5% chance that the events could have happened randomly at this rate. The study showed that there was a 6% chance. Therefore, it was not superior, only roughly equal.