Exanta - French FDA

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Valve-Viking

Well-known member
Joined
Jan 28, 2004
Messages
64
Location
Sweden
The French FDA have asked AstraZeneca for more information pending
their decision whether to approve "Exanta" for a-fib.

"Exanta" is already approved in France and many other European countries
as bridge therapy following hip-transplants and similar surgeries.

If "Exanta" will win further approval for longtime use in France, it will be
very interesting to see the effects of longtime use not only in trials, but
in real use. This will be very important for the possible future use of "Exanta"
as a replacement of warfarin at fuller extent(for mech. valves).

"Exanta" is the first drug candidating to replace warfarin.

Upsides are;
-Keeps INR in same range steadily
-No frequent monitoring of INR required
-Less interactions with foods, other drugs, alcohol

Downsides are;
-concerns about effects on the liver
-no antidote
-cost

I will post again when further news is available.

/
Martin
 
My post was about the position re French approval of Exanta for
a-fib and it does mention both the good and bad sides. I do not
vouch for the pharmaceutical-world at large by spreading this news
in an down to earth objective way. I do believe this is the right place
to post news about anticoagulant drugs?!?

So sorry if I´ve messed up your life by adding further worries to it,
but I think this information is fair and justified.

/
Martin
 

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