New data might help Bayer and Johnson & Johnson ($JNJ) win a new indication for their Xarelto blood thinner. A new analysis of patients in a late-stage trial found that adding the drug to standard therapy with Plavix and aspirin helped cut the risk of death, heart attack or stroke.
The promising data applies to a subgroup of patients in a large trial of Xarelto as a treatment for acute coronary syndrome (ACS). That subgroup--patients who had suffered a severe heart attack known as an ST-segment elevation mycardial infarction (STEMI)--amounted to about 8,000 patients, Reuters reports.
FDA already refused to approve Xarelto as an ACS treatment, despite positive data from the same trial, because of worries about bleeding risks. The drug is approved for stroke prevention in patients with atrial fibrillation, among other uses. An ACS indication could broaden its potential market significantly.
That ACS edge would help Xarelto compete with two other anti-clotting drugs that are designed to be alternatives to the old standard, warfarin. Boehringer Ingelheim's Pradaxa was the first of the three to win approval, while Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) still await the FDA's blessing. Since Pradaxa hit the market, reports of bleeding-related deaths prompted European regulators to request stronger warnings on the drug. The FDA is reviewing reports of at least 256 deaths associated with bleeding in Pradaxa patients.
The latest analysis also pointed up bleeding risks associated with Xarelto. The Xarelto group showed a higher risk of major bleeding, compared with the patients on standard therapy alone. But Xarelto didn't increase the risk of fatal bleeding. As Reuters points out, bleeding is a risk with any anti-clotting treatment.
- read the Reuters news
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