Anti-blood clotting drug prasugrel (Effient) has been launched in India by Glenmark.
Prasugrel is an oral anti-platelet medicine specifically for patients who have undergone an angioplasty procedure to open up a blocked heart artery after experiencing a heart attack or heart-related chest pain at rest (unstable angina) – both these medical conditions are known as acute coronary syndrome.
Prasugrel was approved by the US Food and Drug Administration for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI in 2009.
Prasugrel is considered an increasingly popular new oral anti-platelet drug for the management of acute coronary syndrome with percutaneous coronary intervention.
Percutaneous coronary intervention is better known as the angioplasty procedure which normally includes the placement of a stent to keep the artery open.
Prasugrel will be marketed in India by Glenmark in the brand name Aplet.
Prasugrel (Aplet) offers an effective alternative to current oral anti-platelet drugs which have several limitations including slow onset of action, interpatient variability and possibility of poor or no response in some patient’s especially those who are diabetic, Glenmark said in a press release.
The estimated market size for prasugrel is Rs 3 billion.
Prasugrel, which being currently marketed in the brand name Effient in the US and Efient in EU is developed by Daiichi Sankyo Co. and produced by Ube.
Prasugrel is currently marketed in the United States in cooperation with Eli Lilly and Company.
Prasugrel was approved for use in Europe in February 2009, and is currently available in the UK.
A recent study found that prasugrel (Effient) has been cost-effective for patients with heart disease compared to the leading clot-buster clopidogrel (Plavix).
Results from a health economic sub-study of the TRITON-TIMI 38 clinical trial showed that among patients with acute coronary syndromes (ACS) managed with percutaneous coronary intervention (PCI), including stenting, treatment with Effient (prasugrel) compared with branded clopidogrel (Plavix) was more cost effective, and in most cases cost saving. These results were published in Circulation on January 5, 2010.
TRITON-TIMI 38 was a Phase III, randomized, double-blind, head-to-head clinical trial comparing the effects of Effient versus clopidogrel in patients with ACS who were managed with PCI, a procedure to open blockages in heart arteries, including the use of coronary stenting. The study enrolled 13,608 patients at 707 trial sites in 30 countries.
In the pre-specified analysis of 6,705 patients, treatment with prasugrel (Effient) compared with clopidogrel reduced total hospitalization costs over approximately 15 months, not including the cost of study drugs, by $530 per patient. This cost offset estimate includes bleeding-related costs that a sensitivity analysis showed were not a major driver of the overall cost difference between the two treatments.
The analysis also found that, including cost of the active study drugs as well as costs associated with the initial and subsequent hospitalizations, treatment with Effient compared with clopidogrel decreased cumulative medical costs by $221 per patient over the 14.7-month study.
Study drug costs used in the analysis were the net wholesale price as of August 2009, which was $5.45 per day for prasugrel (Effient) and $4.62 per day for clopidogrel.
“Results of the cost-effectiveness analysis showed that treatment with Effient was highly cost effective and an economically dominant option compared with Plavix,” said David J. Cohen, M.D., M.Sc., director of cardiovascular research, Saint Luke’s Mid America Heart Institute and professor of medicine, University of Missouri-Kansas City.
The economic analysis was completed using data from 6,705 study patients enrolled in eight pre-specified countries, including the United States, Australia, Canada, France, Germany, Italy, Spain and United Kingdom.
Clinical studies have shown that treatment with Prasugrel helps to reduce the risk of a future heart-related event, such as a heart attack or stent clot, in patients who had an ACS event that was treated with angioplasty.