Angiomax, an anticoagulant sold by US firm The Medicines Company, is as effective as standard therapy in opening blocked coronary arteries, but is safer, according to the results of the ACUITY trial.
The data suggest that Angiomax (bivalirudin), a direct thrombin inhibitor, could become an alternative to the 40-year-old gold-standard drug heparin and the related low-molecular weight heparin (LMWH) class in ACS patients.
Heparin is effective but can be difficult to dose correctly and raises the risk of bleeding complications if too much is given.
ACUITY enrolled nearly 14,000 patients with acute coronary syndromes and found that, while the drug was as effective as heparin in reducing death, heart attack and revascularization procedures, bleeding complications happened less frequently. 3% of patients on Angiomax suffered a major bleed, compared to 5.7% of the heparin group.
The study also showed that Angiomax could be combined safely with glycoprotein IIb/IIIa inhibitors such as Eli Lilly’s ReoPro (abciximab) and GlaxoSmithKline/Schering Plough’s Integrilin (eptifibatide), also widely used in ACS patients, although there was no additional benefit over Angiomax monotherapy.
"Results of ACUITY are clear cut and even more robust in favor of Angiomax than the findings of our most recent major Angiomax study, REPLACE-2," said Clive Meanwell, TMC’s Chairman and Chief Executive.
The firm said the results should boost use of Angiomax, currently approved for unstable angina, in the catheterisation lab, and also open up a new area of use for the drug in the emergency department as its use is extended to the broader ACS population.
Analysts at Datamonitor said growth in the latter should come although there will be a time lag as emergency room protocols will need to be updated to include the new agent, and there are also cost-considerations that need to be addressed.
TMC reported sales of Angiomax of around $150 million last year, somewhat lower than hoped for by some analysts.