Valve-Viking
Well-known member
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
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