US approval boosts Plavix competitor
pharmafile | July 14, 2009 | News story | Research and Development, Sales and Marketing | Effient, FDA, US, lilly
US regulator the FDA has approved Lilly and Daiichi Sankyo's Effient, a rival treatment to the world's best-selling blood-thinning drug Plavix.
It is a boost to Effient's co-developers, who previously saw the drug delayed over safety concerns, but now hope it will come to the fore as Plavix nears patent expiry.
Effient (prasugrel) helps keep blood platelets from sticking together to form clots, which can block an artery. The FDA has approved it for people who have acute coronary syndrome (ACS) and it will be given following a PCI procedure (angioplasty) to reopen a blocked artery.
Patients who undergo this surgery are at risk of developing a blood clot, and taking Effient should help cut the number of heart attacks or strokes in these patients.
Takashi Shoda, president and chief executive of Daiichi, said: "After more than a decade of research and testing, we are proud to provide this new treatment option to patients with ACS who are managed with PCI."
Sanofi-Aventis and BMS' Plavix currently leads the ACS market, but Effient, which is also approved in Europe, is gathering momentum.
Effient should be launched in the US in the coming weeks, increasing the reach of the ascendant treatment.
Although it is not expected to overhaul Plavix as the established drug has a wealth of data behind it and is familiar to doctors, the newer drug has shown promising results, despite safety concerns over uncontrolled bleeding seen in some patients.
A head-to-head trial comparing Effient to Plavix – called TRITON-TIMI 38 – found that the former was 19% more effective in reducing MI, stroke and cardiovascular death in ACS patients who underwent a PCI, such as angioplasty.
The company say an analysis of the trial, weighing the risk of major bleeding and the reduction in cardiovascular events, showed the overall benefit was higher with Effient.
For every 1,000 patients treated with Effient as compared with Plavix, there were 23 fewer patients with heart attacks and six more with major bleeding events.
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