EXCLUSIVE: New Antiplatelet Therapy Could Save Limbs, Says Merck & Co. Exec
July 2, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
New data on effect of an antiplatelet therapy on cardiovascular outcomes in patients with peripheral arterial disease is showing enormous promise, an executive with Merck & Co. told BioSpace Thursday, as changes in the field grow.
Jay Horrow, a medical doctor and executive director for Global Clinical Development Merck & Co., said recent data presented by the TIMI Group at the Society of Vascular medicine has the potential to demonstrate this limb-saving property. BioSpace chatted with Harrow about why this particular data is so intriguing—and what it could mean for the standard of care going forward.
BIOSPACE: Key takeaways from this report?
Preventing major adverse limb events – acute limb ischemia, amputation, and peripheral revascularization – in patients with peripheral arterial disease represents a significant unmet medical need. Vorapaxar, already approved in the U.S. to reduce major adverse cardiac events, has the potential to also prevent major adverse limb events these patients.
BIOSPACE: Explain what’s remarkable or interesting about this research?
No medicine to date has demonstrated an ability to reduce the incidence of acute limb ischemia – a condition in which blood flow to an extremity reduces sharply, placing the limb at risk for amputation. These data from the TRA-2P TIMI 50 trial suggest that vorapaxar has the potential to demonstrate this limb-saving property. Similar to the effects of other anti-platelet medications, bleeding side-effects can accompany the risk reduction with vorapaxar.
BIOSPACE: What’s the size of the market it is hoping to break into?
Heart attacks are generally caused by atherosclerotic plaque disruption and thrombus (blood clot) formation in a coronary artery. There are approximately 7.6 million Americans who have survived a heart attack. Each year, about 720,000 Americans have a new (515,000) or recurrent (205,000) heart attack.
Peripheral arterial disease (PAD) is generally defined as obstruction of arteries supplying the lower or upper extremities, most commonly due to atherosclerosis and much more commonly involving the lower extremities. About 8.5 million individuals in the U.S. have PAD, of whom approximately 10 percent have classic claudication symptoms (i.e., calf muscle pain on exertion), and another 50 percent have other leg symptoms. People with PAD are at increased risk for heart attack, stroke and cardiovascular death.
BIOSPACE: How does it stack up to other therapies of its type?
ZONTIVITY is the first and only therapy shown to inhibit the protease-activated receptor-1 (PAR-1) expressed on platelets. The PAR-1 receptor is the primary receptor for thrombin, which is considered to be the most potent activator of platelets. The PAR-1 pathway participates in the formation of blood clots through the activation and aggregation of platelets. ZONTIVITY addresses this additional pathway that is not targeted by acetylsalicylic acid (ASA or aspirin) or P2SY12 inhibitors, like clopidogrel. ZONTIVITY should be used with aspirin and/or clopidogrel according to their indications or standard of care. It has not been studied as monotherapy. There are no head-to-head studies.
BIOSPACE: What’s the timeline for regulatory approval?
The FDA approved ZONTIVITY (vorapaxar) in May 2014 for the reduction of thrombotic cardiovascular events in patients with a history of heart attack (myocardial infarction) or in patients with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction, stroke, and urgent coronary revascularization.
ZONTIVITY is contraindicated in patients with a history of stroke, transient ischemic attack, or intracranial hemorrhage (ICH), as well as in patients with active pathological bleeding such as ICH or peptic ulcer.
After Bristol-Myers Squibb Wonder Drug Meets Endpoints, Will FDA Process Be Up to Snuff?
Our most popular story last week was about a new wonder drug that wowed the FDA. An experimental anticoagulant drug under joint development between Portola Pharmaceuticals, Inc., Bristol-Myers Squibb Company and Pfizer Inc. met all primary and secondary endpoints in a Phase III study determining safety and efficacy—and our readers responded. The hope now is it will be sped to patients as fast as possible.
That’s lead BioSpace to ask, what do you think about the drug approval process in this country? Let us know your ideas.