Zontivity (vorapaxar), Merck’s Cardio Drug Approval by FDA: Will it Challenge existing Oral Anticoagulation drugs: i.e., Apixaban, Dabigatran, Edoxaban, Rivaroxaban

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Zontivity (vorapaxar), Merck’s Cardio Drug Approval by FDA: Will it Challenge existing Oral Anticoagulation drugs: i.e., Apixaban, Dabigatran, Edoxaban, Rivaroxaban

May 10, 2014 by 2012pharmaceutical

Zontivity (vorapaxar), Merck’s Cardio Drug Approval by FDA: Will it Challenge existing Oral Anticoagulation drugs: i.e., Apixaban, Dabigatran, Edoxaban, Rivaroxaban

Curator: Aviva Lev-Ari, PhD, RN

UPDATED on 8/16/2016

The presence of any VHD did not influence the comparison of Dabigatran [Pradaxa, Boehringer Ingelheim] with warfarin

It is important to note that similar to RE-LY, 14% of patients in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) trial and 26% of patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial had heart-valve disease other than prosthetic valve disease or significant mitral valve stenosis.

Two other post hoc analyses looked at outcomes with rivaroxaban (Xarelto, Bayer/Johnson) vs warfarin in the ROCKET-AF trial and apixaban ( Eliquis, Bristol-Myers Squibb/Pfizer) vs warfarin and in the ARISTOTLE trial—specifically in patients with valvular heart disease.

Taken together, “the evidence regarding the value of NOACs in patients with [valvular heart disease] as defined in the three studies is very strong” and is reflected in the recent European and American guidelines, according to Ezekowitz et al.

This analysis was sponsored by a research grant from Boehringer-Ingelheim Pharmaceuticals. Ezekowitz has served as a consultant for AstraZeneca, Eisai, Pozen, Boehringer Ingelheim, ARYx Therapeutics, Pfizer, Sanofi, Bristol-Myers Squibb, Portola, Daiichi Sankyo, Medtronic, Merck, Johnson & Johnson, Gilead,Janssen Scientific Affairs, and Armetheon. He has received grants from Boehringer Ingelheim, Bayer, Daiichi Sankyo, Pfizer, and Bristol-Myers Squibb. Disclosures for the coauthors are listed in the article.

SOURCE

http://www.medscape.com/viewarticle/867482?nlid=108872_3866&src=WNL_mdplsfeat_160816_mscpedit_card&uac=93761AJ&spon=2&impID=1179558&faf=1

Merck’s Statement

The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

Zontivity is the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist. It is an anti-platelet agent, designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke.

Like other drugs that inhibit blood clotting, Zontivity increases the risk of bleeding, including life-threatening and fatal bleeding. Bleeding is the most commonly reported adverse reaction in people taking Zontivity. The drug’s prescribing information (label) includes a Boxed Warning to alert health care professionals about this risk.

Zontivity must not be used in people who have had a stroke, transient ischemic attack (TIA), or bleeding in the head, because the risk of bleeding in the head is too great.

“In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death. In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5 percent to 7.9 percent over a 3-year period – about 0.5 percent per year,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.

Health care professionals should inform patients that they may bleed and bruise more easily when taking Zontivity. Patients should report to their health care professional any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine. Zontivity will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information.

In a clinical trial with over 25,000 participants, Zontivity, added to other anti-platelet agents (generally aspirin and clopidogrel), reduced the rate of a combined endpoint of heart attack, stroke, cardiovascular death, and urgent procedures to improve blood flow to the heart (coronary revascularization) when compared to an inactive pill (placebo).

Zontivity is made by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. of Whitehouse Station, N.J.

For more information:

SOURCE
FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients – FierceBiotech http://www.fiercebiotech.com/press-releases/fda-approves-zontivity-reduce-risk-heart-attacks-and-stroke-high-risk-patie#ixzz31LmW3uCv

Entrenched Competition to Zontivity (vorapaxar), Merck’s Cardio Drug Apixaban, Dabigatran, Edoxaban, Rivaroxaban

See the following

Coagulation Therapy: Leading New Drugs – Efficacy Comparison
Curator: Aviva Lev-Ari, PhD, RN
This article consists of a bibliography of Curations and Reporting on this topic by Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2014/05/10/coagulation-therapy-leading-new-drugs-efficacy-comparison/

Apixaban (Eliquis): Mechanism of Action, Drug Comparison and Additional Indications
Curator: Aviva Lev-Ari, PhD, RN
https://pharmaceuticalintelligence.com/2014/05/10/apixaban-eliquis-mechanism-of-action-drug-comparison-and-additional-indications/

Table 1

SOURCE

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3670724/

Merck wins FDA approval for a once-vaunted cardio drug

May 8, 2014 | By Damian Garde

The pill, to be marketed as Zontivity, is a first-in-class inhibitor of PAR-1, stopping the receptor from interacting with thrombin and thus halting platelets from forming blood clots. The drug is approved to reduce risk of heart attack, stroke and other cardiovascular events in patients who have already endured a heart attack or who have peripheral arterial disease. In its pivotal data submitted to the FDA, vorapaxar lowered stroke risk from 9.5% to 7.9% over three years, the agency said.

However, Merck’s cardio contender carries some serious bleeding risks, and the FDA has slapped a black-box warning on the drug to advise physicians of the potential for fatal episodes. As expected, vorapaxar is contraindicated for patients who have already had strokes or transient ischemic attack, excising a sizable patient population and dampening sales projections.

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The well-traveled treatment was a major factor in Merck’s $41 billion buyout of Schering-Plough back in 2009, singled out as a pill with a blockbuster future with the potential to beat out tried-and-cheap warfarin and notch peak sales of up to $5 billion a year. Within three years, however, serious bleeding risks came to light, leading Merck to leave out stroke patients from its FDA application and thereby trim some of vorapaxar’s potential market.

But the drugmaker remains confident its cardio drug has a bright commercial future. About 7.6 million Americans have suffered a heart attack, Merck has said, and about 190,000 eventually have a recurrent episode, creating a sizable unmet need.

Meanwhile, the Whitehouse Station, NJ, pharma giant is in the midst of an R&D realignment, which includes a renewed focus on cardiovascular therapies. Alongside the Phase III atherosclerosis drug anacetrapib, vorapaxar was the second late-stage pillar in Merck’s thin cardio pipeline, but the drugmaker has since struck up a deal worth up to $2.1 billion with Bayer, signing up to share rights to the pulmonary arterial hypertension treatment Adempas and collaborate on some in-development heart failure candidates.

– read the statement

SOURCE
Merck wins FDA approval for a once-vaunted cardio drug – FierceBiotech http://www.fiercebiotech.com/story/merck-wins-fda-approval-once-vaunted-cardio-drug/2014-05-08#ixzz31LorKNEw

Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com

Zontivity (vorapaxar), Merck’s Cardio Drug Approval by FDA: Will it Challenge existing Oral Anticoagulation drugs: i.e., Apixaban, Dabigatran, Edoxaban, Rivaroxaban

Zontivity (vorapaxar), Merck’s Cardio Drug Approval by FDA: Will it Challenge existing Oral Anticoagulation drugs: i.e., Apixaban, Dabigatran, Edoxaban, Rivaroxaban

Entrenched Competition to Zontivity (vorapaxar), Merck’s Cardio Drug Apixaban, Dabigatran, Edoxaban, Rivaroxaban

Merck wins FDA approval for a once-vaunted cardio drug

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Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com

Zontivity (vorapaxar), Merck’s Cardio Drug Approval by FDA: Will it Challenge existing Oral Anticoagulation drugs: i.e., Apixaban, Dabigatran, Edoxaban, Rivaroxaban

Zontivity (vorapaxar), Merck’s Cardio Drug Approval by FDA: Will it Challenge existing Oral Anticoagulation drugs: i.e., Apixaban, Dabigatran, Edoxaban, Rivaroxaban

Entrenched Competition to Zontivity (vorapaxar), Merck’s Cardio Drug Apixaban, Dabigatran, Edoxaban, Rivaroxaban

Merck wins FDA approval for a once-vaunted cardio drug

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