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FDA on the Brilinta approval

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CDER Director Janet Woodcock discusses the label for Brilinta (ticagrelor) by AstraZeneca

Hi i’m steven greer with the healthcare channel we’re here at the fda headquarters in white oak and we’re speaking with dr. janet wilcock who is the director of cder which oversees anything pharmaceutical related and we thought it would be interesting to topic to talk to you because the year 2011 has had more innovative new molecular entities approved that make a

Tremendous difference to the outcome meet unmet medical needs than i can remember since i’ve been covering the drug industry in other years there’s been just what we call me to drugs that are just the same as another drug so i want to talk about why is this just luck or why is this all happening now and they are there new trial designs that are making this possible

So let’s start just for newsworthy sake with the class of medical of cardiovascular anticoagulation blood thinners because yesterday you approved brilinta or tech egregore and earlier in the year was the rel toe by johnson johnson and then early last year was pradaxa now can you explain what unmet medical need why are those a big deal compared discussing warfarin

Well the first one brilinta is really part of the quest to have a better agent during interventions or acute coronary syndrome and so forth so that was a result of superiority trial that showed that berlinda actually did better on the cardiovascular outcomes that were studied than clopidogrel which was a comparator in a worldwide trial alright for the other two

Agents what we’re seeing now is some oral anticoagulants that may be able to be used instead of warfarin and this is an unmet medical need because we know about half the people maybe who should be on warfarin aren’t taking it either they’ve had trouble with maintaining their anticoagulation or their contraindications for them to be on it or they’re too afraid

To be on warfarin and so we have a new generation coming of oral agents hopefully that will have the same or better effects with a lot fewer bleeding of this and they theoretically are on the label it does the label require inr and and in blood testing to see whether your blood is clotting too long or too slow does the can you discuss the label of pradaxa and

Xarelto as compared to what warfarin label is most far as monitoring these drugs do not require the same kind of monitoring that warfarin does okay because they are impacted by all the genetic dietary all these different factors that played into warfarin being such a difficult drug to manage and clinical practice so basically these are rural drugs that you can

Just take at the given dose have practical monitoring by the physician and not require inr or monitoring like that and are they not effective enough or just simply not studied yet to be able to say that if someone has a heart valve with it your fibrillation why is it for non valvular we do approvals based on evidence and so we have evidence from the trials and so

We started out with the approval in from the trials that were done in the norn valvular okay and i want to touch upon a bigger issue here because brilinta take a girl or was delayed in its approval and and all three of those anticoagulants have used very large trials because the outcome they were measuring with stroke is very small you have to have thousands of

Patients and the only way they thought we were able to do it in a cost-effective way was to recruit from all over the world from south america to small eastern bloc countries to india now as we discussed earlier in our previous interview with you that’s a problem that the fda is addressing because you can’t monitor those studies as well as indiana or something

So berlinda was a poster child so to speak for that and and have you have made any progress in the last since the last time we spoke at the fda about how are you gonna are you going to give certain countries a green light or a stamp of approval or how are you going to handle this well first of all let’s discuss the problem with valenta which was discussed at the

Advisory committee which was although there was a superiority finding across the world really wasn’t the same in the us and the question there is when we see differences around the world is it genetic is that the background standard of care is different or there’s some other factors that cause these variability sometimes we see this variability by chance as well

So it took us a while to sort out and the new berlin to label has strong warnings about the aspirin dose that should be used because we after extensive analysis found the united states and north america in general used higher aspirin doses in the trial than other countries which adhere more to the load very low dose aspirin a paradigm so that’s what we did there

Not to your broader question we are trying to do several things to have good coverage of clinical trials around the world the main thing is work with other regulators in other countries to make and develop harmonized standards on conduct of clinical trials which we do have as well as making sure that their inspections of you know samples from different parts of

The world so that we have an idea what’s going on have you thought of just making a certified list of approved countries or medical centers around the world because you’ve inspected them you have a certain level of confidence have you maybe we know about what has been inspected in previous inspections we also share information with other regulators but it’s hard

To have an approved less because sometimes people do a good job on one trial and in fact then later maybe they’d be a different set of investigators in the hospital or whatever and we might not get the same results so it’s a complicated and very challenging situation for us

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FDA on the Brilinta approval By The Healthcare Channel