Efient fails to prove superiority to Plavix
pharmafile | August 29, 2012 | News story | | Brillinta, Efient, Plavix, prasugrel, ticagrelor
Daiichi Sankyo and Lilly’s heart drug Efient has failed to come up to the mark in a late-stage trial which was expected to prove its effectiveness.
The phase III TRILOGY ACS (acute coronary syndrome) trial compared Efient (prasugrel) plus aspirin to standard of care Plavix (clopidogrel) plus aspirin in heart patients.
The failure is good news for AstraZeneca, whose Brilinta (ticagrelor) has previously been proved more effective than Plavix, Sanofi and BMS’s recently off patent drug which is the standard of care.
Brilinta was already predicted to reach blockbuster status, with estimated peak annual sales of up to $3 billion.
Efient was being tested in patients with unstable angina or non-ST elevation myocardial infarction, who were being cared for without an artery-opening procedure.
At 30 months, 13.9% of patients in the Efient arm experienced heart attack, stroke or cardiovascular death, compared with 16% in the Plavix arm – a difference that is not statistically significant.
This meant the primary objective of demonstrating the drug’s superiority in this patient population was not met, although the companies put a brave face on the disappointing news.
“While this is not the outcome we anticipated, we believe this study contributes to the knowledge base about ACS patients who are medically managed,” said Glenn Gormley, Daiichi Sankyo’s global head of R&D.
The companies say they will present further data from the platelet function sub-study, analyses of the elderly population data, as well as genomics information in future peer-reviewed forums.
Efient was approved by the European Commission in February 2009 for the prevention of atherothrombotic events in ACS patients, when co-administered with acetylsalicylic acid.
This green light was based on the results of another trial, TRITON-TIMI 38, where almost all ACS patients underwent percutaneous intervention.
Plavix, which reduces the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries, has patent protection in Europe until next year – although a loophole means generic versions are already available.
Adam Hill
Related Content
AstraZeneca’s Brilinta protects against adverse cardiovascular events for up to 5 years, new data reveals
AstraZeneca has revealed new data supporting the long-term use and efficacy of its cardiovascular drug …
Sanofi lowers Q3 sales figures from 2015
Sanofi lowered its aggregate sales figure for Q3 2016 from €9.59 billion to €9.46 billion …
Thousands to benefit with new anti-clotting drug recommendation, says NICE
The National Institute for Health and Care Excellence (NICE) has published new draft guidance recommending …
