Monday, June 30, 2014


Boehringer Ingelheim has just announced that the US FDA has granted breakthrough therapy designation to its new investigational drug, Idarucizumad, an antidote for Dabigatran ( Pradaxa ). They have began enrolment for their phase 3 clinical trial, Re-Verse-AD, to study the safety of this new humanised antibody fragment.

Dabigatran suffers from the fact that dosing is difficult and for patients who need unscheduled surgery, bleeding has become a major issue. In fact, 5,000 over law suits have been filed for bleeding and BI is in the midst of settling many of them. 
With this breakthrough therapy status, BI can fast forward their trials and apply quickly for approval pending the results.
All this also means that BI recognises that bleeding is a major concern with Dabigatran as it is with warfarin. With warfarin, we have the option to reverse with Vitamin K.

Lets see what comes out from Re-verse-AD?


Winston Yap said...

Doctor, I think that there are many drugs out there which shouldn't be so.
Because they have very serious side effects.
That's why there is a warning in all their instruction leaflets that patients are taking their medications because the "benefits" outweigh the risks.
In fact, the risks are many and some of them are very serious.
And there's no way of finding out until one has taken the medicines!!!
By then, it will be far too late.
I think that the FDA or other controlling bodies must make sure that such serious kinks must be ironed out before the pharmacies are allowed to market these drugs.

hmatter said...

I agree with you. I am also very concerned. Some of the newer recently FDA approved drugs have rather low therapeutic index, and in my opinion should never have been approved. FDA is no longer for patient. Looks like they are pro-pharma. Local experts are being flown around all over the world so they have also become pro-pharma. So sad. In the end, it is all about money.