Prasugrel — a rival to Plavix from Sanofi-Aventis and Bristol-Myers Squibb is a key product for Lilly and Daiichi. But its path to market has been delayed and the drug has been associated with serious bleeding. That has left doctors debating how it might best be used, assuming it is approved by regulators.
Industry analysts believe the agency’s decision to delay on whether to approve the product could be due to uncertainty over how to define precisely which patients should use it.
Patients with diabetes who also had acute coronary syndromes were 40 percent less likely to suffer a subsequent heart attack when taking prasugrel instead of Plavix, according to updated results from Lilly and as told by the experts in the annual meeting of the European Society of Cardiology. In non-diabetics, there was a much smaller difference.
Acute coronary syndromes are a range of heart problems caused by hardening of the arteries, including heart attack and chest pain. People with diabetes are at increased risk for the problems.
In people without diabetes, Lilly said 9 percent of patients taking its drug experienced heart attack or stroke, compared with 11 percent of patients on Plavix, which is sold by Sanofi-Aventis SA and Bristol-Myers Squibb Co.
The findings suggest that a more powerful drug may be more effective in the growing group of diabetic patients who are at high risk of suffering a second heart attack.
The Food and Drug Administration is expected to issue a decision this month on the blood-clotting drug, which was co-developed with Japanese drugmaker Daiichi Sankyo Co. The agency delayed a decision on prasugrel in June, saying it would need an additional three months to complete its review.
Like other blood thinners, prasugrel prevents platelets from sticking together and forming a clot.
source : Reuters