vorapaxar (Zontivity) Appoved

[Anonymous]

ST PAUL, MN — The US Food and Drug Administration has approved vorapaxar (Zontivity, Merck Sharpe & Dohme), a novel protease-activated receptor 1 (PAR-1) inhibitor, to reduce the risk of MI, stroke, cardiovascular death, and need for revascularization procedures in patients with a previous MI or peripheral artery disease[1].

This is a first-in-class approval for this antiplatelet medication.

The approval comes after a January meeting of the Cardiovascular and Renal Drugs Advisory Committee voted 10 to 1 in favor of approving vorapaxar in this setting. The drug will be packaged with a boxed warning alerting physicians to the risk of bleeding and is contraindicated in people who have had a stroke, transient ischemic attack (TIA), or intracranial hemorrhage because of the increased bleeding risk.

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Information from Industry
The basis for approval is from the TRA 2°P TIMI-50 clinical trial. Reported by heartwire when it was presented in 2012 at the American College of Cardiology Scientific Sessions , the 26 499-patient study showed that time to cardiovascular death, MI, stroke, or urgent coronary revascularization was reduced by 13% in patients taking 2.5 mg of vorapaxar. When coronary revascularization was excluded, the secondary end point of cardiovascular death, MI, or stroke was also significantly reduced.

On the downside, moderate or severe bleeding occurred in 4.2% of patients treated with vorapaxar compared with 2.5% in the placebo-treated patients, a statistically significant 66% increase.

References

 

[Anonymous]

Whos going to sell this exciting new product?

 

[Anonymous]

Correct me if I'm wrong but isn't this a Schering drug, seems like Schering is keeping this company afloat. We are the doers not the box checkers.

 

[Anonymous]

More smoke and mirrors. This drug will be a dog. Contra indicated in patients who have had a stroke due to bleeding risk. There are safer alternatives with similar outcomes. I doubt doctors are going to gamble on writing this one.

 

[Anonymous]

More smoke and mirrors. This drug will be a dog. Contra indicated in patients who have had a stroke due to bleeding risk. There are safer alternatives with similar outcomes. I doubt doctors are going to gamble on writing this one.

Genius with a negatiity disease. This is novel and has a place in the management of patients with no history of stroke.

 

[Anonymous]

Correct me if I'm wrong but isn't this a Schering drug, seems like Schering is keeping this company afloat. We are the doers not the box checkers.

Indeed, another approval from SPRI.

 

[Anonymous]

More smoke and mirrors. This drug will be a dog. Contra indicated in patients who have had a stroke due to bleeding risk. There are safer alternatives with similar outcomes. I doubt doctors are going to gamble on writing this one.

The company already took a 1.7 billion dollar write off on this drug because it won't be used where originally hoped for i.e. in the acute care setting. FDA has simply relegated the drug with a consolation prize and says must only use in triple therapy combination with plavix and aspirin only after a patient has had history of an MI. This is not the good news we had originally hoped for this drug. Patients won't pay for this drug and also plavix at the same time. Only expected to result in less than half a percent risk reduction but black box warning of deadly bleeding if patient has prior stroke or TIA. That's the issue here. Elderly patients who have silent strokes or history of unreported TIA are at huge risk with this drug! Doctors cannot and will not perform a CT scan on every patient to see if they have had a prior TIA or silent stroke. Taking a real gamble prescribing this drug. Very poor risk benefit ratio here and the small if any risk reduction won't offset the cost (several hundred dollars plus per month) of this drug vs. current use of plavix plus aspirin. This drug is not listed anywhere in the cardiology treatment guidelines protocols for treatment of post MI, and therefore will not be covered on any of the managed care plans for at least a year or two post launch. There is no excitement in the medical community for this drug.

 

[Anonymous]

The company already took a 1.7 billion dollar write off on this drug because it won't be used where originally hoped for i.e. in the acute care setting. FDA has simply relegated the drug with a consolation prize and says must only use in triple therapy combination with plavix and aspirin only after a patient has had history of an MI. This is not the good news we had originally hoped for this drug. Patients won't pay for this drug and also plavix at the same time. Only expected to result in less than half a percent risk reduction but black box warning of deadly bleeding if patient has prior stroke or TIA. That's the issue here. Elderly patients who have silent strokes or history of unreported TIA are at huge risk with this drug! Doctors cannot and will not perform a CT scan on every patient to see if they have had a prior TIA or silent stroke. Taking a real gamble prescribing this drug. Very poor risk benefit ratio here and the small if any risk reduction won't offset the cost (several hundred dollars plus per month) of this drug vs. current use of plavix plus aspirin. This drug is not listed anywhere in the cardiology treatment guidelines protocols for treatment of post MI, and therefore will not be covered on any of the managed care plans for at least a year or two post launch. There is no excitement in the medical community for this drug.

Interesting, new drug approval and stock keeps dropping. Enough said.

 

[Anonymous]

The company already took a 1.7 billion dollar write off on this drug because it won't be used where originally hoped for i.e. in the acute care setting. FDA has simply relegated the drug with a consolation prize and says must only use in triple therapy combination with plavix and aspirin only after a patient has had history of an MI. This is not the good news we had originally hoped for this drug. Patients won't pay for this drug and also plavix at the same time. Only expected to result in less than half a percent risk reduction but black box warning of deadly bleeding if patient has prior stroke or TIA. That's the issue here. Elderly patients who have silent strokes or history of unreported TIA are at huge risk with this drug! Doctors cannot and will not perform a CT scan on every patient to see if they have had a prior TIA or silent stroke. Taking a real gamble prescribing this drug. Very poor risk benefit ratio here and the small if any risk reduction won't offset the cost (several hundred dollars plus per month) of this drug vs. current use of plavix plus aspirin. This drug is not listed anywhere in the cardiology treatment guidelines protocols for treatment of post MI, and therefore will not be covered on any of the managed care plans for at least a year or two post launch. There is no excitement in the medical community for this drug.

Question: How prevalent is silent stroke in elderly patients?

Answer: At the annual meeting of the American Stroke Association, the results of a study from UCLA Medical Center found that in addition to having more than one silent stroke in a year, most Americans have 22 million silent strokes annually. The prevalence of silent stroke doubles every 10 years in patients over the age of 30. By the time people reach their 70's, one in three has a silent stroke every year. Silent stroke can only be detected by routine brain scans, MRI's which doctors do not ordinarily perform.

Problem: Are doctors going to order an MRI on every patient before prescribing Zontivity?
Furthermore, will doctors continue to order routine MRI's to monitor these high risk patients for future silent strokes prior to maintaining treatment with Zontivity?

 

[Anonymous]

The Black Box and very limited patient population make this approval a complete non-issue. It's a $10MM drug at best.

 

[Anonymous]

Genius with a negatiity disease. This is novel and has a place in the management of patients with no history of stroke.

Nice to see all the supporting posts to my 'negativity diseased' one following this one. This drug is going to barely eek out any revenue at all for all the reasons between your post and this reply.

 

[Anonymous]

If I was a doc I would not write it based on the name alone.....where in the heck do they come up with these stupid names

 

[Anonymous]

If I was a doc I would not write it based on the name alone.....where in the heck do they come up with these stupid names

lol...so true! This sounds like a name you would give to a dance aerobic routine or maybe an energy drink, but sure as hell NOT a CV drug. Good Lord.

 

[Anonymous]

If I was a doc I would not write it based on the name alone.....where in the heck do they come up with these stupid names

That name cost us 5-10 million dollars. There is a great deal of marketing associated with that stuff

 

[Anonymous]

Correct me if I'm wrong but isn't this a Schering drug, seems like Schering is keeping this company afloat. We are the doers not the box checkers.

Zzzzzzzontivity, why all the hype. This will dish out Propecia type money. If we are promoting this we might as well throw Suvorexxxant to pc. Combined, both drugs will barely cover the rsu grants for our top suits. I hope it does well as we have good talent in those spots but the numbers don't make sense. Come on RP, buy some billion dollar drugs, the Buyer stuff was a foolish move. Bet Fast Freddie had his hands in the candy jar.

 

[Anonymous]

The company already took a 1.7 billion dollar write off on this drug because it won't be used where originally hoped for i.e. in the acute care setting. FDA has simply relegated the drug with a consolation prize and says must only use in triple therapy combination with plavix and aspirin only after a patient has had history of an MI. This is not the good news we had originally hoped for this drug. Patients won't pay for this drug and also plavix at the same time. Only expected to result in less than half a percent risk reduction but black box warning of deadly bleeding if patient has prior stroke or TIA. That's the issue here. Elderly patients who have silent strokes or history of unreported TIA are at huge risk with this drug! Doctors cannot and will not perform a CT scan on every patient to see if they have had a prior TIA or silent stroke. Taking a real gamble prescribing this drug. Very poor risk benefit ratio here and the small if any risk reduction won't offset the cost (several hundred dollars plus per month) of this drug vs. current use of plavix plus aspirin. This drug is not listed anywhere in the cardiology treatment guidelines protocols for treatment of post MI, and therefore will not be covered on any of the managed care plans for at least a year or two post launch. There is no excitement in the medical community for this drug.

Glad to see that Zontivity is being manufactured in the Singapore facility where quality control and a clean, radioactive free water supply are of the highest reliability standards......yikes!