Vorapaxar's fate on Wednesday

[Anonymous]

CCR rep here, It will be very interesting to see how the FDA's cardiovascular and renal group votes tomorrow on Vorapaxar. The FDA's own scientists seem to have given the drug the green light to be approved for a limited indication. We will see how
Dr. Lincoff and others view the data. Any thoughts from others?

 

[Anonymous]

Would you want to take it if you knew it could cause intracranial bleeding? Pass.

 

[Anonymous]

It sounds like another Merck product to me. Of little to no benefit, but occasionally kills people.

 

[Anonymous]

Would you want to take it if you knew it could cause intracranial bleeding? Pass.

Exactly. A sea of safer, cheaper generics will also make reimbursement a challenge.

We wrote off most if the research costs on this dog in 2011. Why it wasn't just killed off, I'd love to know.

 

[Anonymous]

Would you want to take it if you knew it could cause intracranial bleeding? Pass.

Even greater risk of intracranial bleeding if patient had a prior stroke. So, there may be an indication on the label not to prescribe to a patient who has had a prior stroke, this is the real liability. Many elderly folks can have silent or previously undiagnosed strokes and the doctor has no way of knowing before they prescribe this drug. There really is no unmet need for this drug, and I see no perfect patient under these criteria.

 

[Anonymous]

CCR rep here, It will be very interesting to see how the FDA's cardiovascular and renal group votes tomorrow on Vorapaxar. The FDA's own scientists seem to have given the drug the green light to be approved for a limited indication. We will see how
Dr. Lincoff and others view the data. Any thoughts from others?

I think the Advisory Committee will vote to recommend approval for the limited indication. I do not think they will recommend any further trials.

 

[Anonymous]

The chair of the FDA session will be Dr. Mike Lincoff from the Clev clinic and it will be interesting to see if Dr. Nissen influences his decision tomorrow. Dr. Nissen's comments were very negative about Vorapaxar at the ACC meeting a few years ago when a panel discussion reviewed the TRA TIMI 50 data. Tomorrow should be interesting.

 

[Anonymous]

The chair of the FDA session will be Dr. Mike Lincoff from the Clev clinic and it will be interesting to see if Dr. Nissen influences his decision tomorrow. Dr. Nissen's comments were very negative about Vorapaxar at the ACC meeting a few years ago when a panel discussion reviewed the TRA TIMI 50 data. Tomorrow should be interesting.

I wonder if Merck has already been told what the decision will be? Some people are saying that there are mandatory teleconferences tomorrow.

 

[Anonymous]

Lincoff did not chair the committee. The vote was 10- 1 in favor of Vorapaxar. Why: "robust Efficacy". Benefit risk clearly outweighed by benefit. ICH not significant in No Prior. Stroke or TIA. Will have indication based on tra 2 p NOT Tracer trial which is where the ICH was seen in prior stroke Acs patients. Who where probably over anticoagulant to begin with. Zontivity will fulfill an unmet need as standard of care Asa/ p 2y12 after discharge were the placebo arm and AGAIN efficacy was seriously robust with p values with lots of zeros with the addition of Zontivity after 2 weeks from Mi. This is not for acute care but will benefit patients from having an additional Mi down the road. Lets be positive folks and not so negative Nellie unless you work for a competitor than you should be a nervousness Nellie.

 

[Anonymous]

Lincoff did not chair the committee. The vote was 10- 1 in favor of Vorapaxar. Why: "robust Efficacy". Benefit risk clearly outweighed by benefit. ICH not significant in No Prior. Stroke or TIA. Will have indication based on tra 2 p NOT Tracer trial which is where the ICH was seen in prior stroke Acs patients. Who where probably over anticoagulant to begin with. Zontivity will fulfill an unmet need as standard of care Asa/ p 2y12 after discharge were the placebo arm and AGAIN efficacy was seriously robust with p values with lots of zeros with the addition of Zontivity after 2 weeks from Mi. This is not for acute care but will benefit patients from having an additional Mi down the road. Lets be positive folks and not so negative Nellie unless you work for a competitor than you should be a nervousness Nellie.

Patients discharged after an MI and receiving a drug eluting stent will discontinue their p2y12 within 12 months and won't need to be on vorapaxar long term either. This is not a long term chronic medication, folks. No long term chronic use = no long term money. No acute care usage = another primary care drug.

 

[Anonymous]

Let Todd Nichols lead this doomed team, and leave the vaccine people alone already.