FRANKFURT, Aug 27 (Reuters) - Bayer said results from a late-stage clinical trial showed its anti-clotting pill Xarelto cut the risk of recurrence in patients who have suffered a severe heart attack, as it strives to secure U.S. approval for wider use of the drug.
Results from the trial showed that adding Xarelto to standard therapy - typically aspirin and Sanofi’s Plavix - significantly reduced cardiovascular death, heart attack or stroke compared with standard therapy alone.
The results came from the analysis of a sub-group of patients in a wider drug trial that tested the blood clot preventer on patients with acute coronary syndrome (ACS).
Based on the wider trial, U.S. regulators in June declined to extend the use of Xarelto to include ACS patients due to concerns over bleeding risks.
Bayer and development partner Johnson & Johnson are currently trying to answer the FDA’s questions to secure an approval.
Patients with ACS have had heart attacks or chest pains that indicate the risk of a heart attack. About 30 percent of ACS patients have actually suffered a severe form of heart attack, so-called ST-segment elevation myocardial infarction (STEMI),
Those were the subject of the study which was published on Monday. STEMI typically involves an obstructed coronary artery, leading to damage of the heart muscle tissue.
In the narrower analysis with about 8,000 participants, patients on Xarelto incurred a higher risk of major bleeding - a typical concern linked to any anti-clotting treatment - than those on standard treatment alone. Xarelto, however, did not increase the rate of fatal bleeding, Bayer added.
Bayer has submitted Xarelto for European approval for prevention of heart attacks in ACS patients and is expecting a decision by the end of this year.