Bayer AG and Johnson & Johnson won European backing to expand marketing of their blood-thinner Xarelto to a group of heart-disease patients that U.S. authorities have been reluctant to clear for use of the drug.
The European Medicines Agency’s drug advisory board today recommended Xarelto be approved to prevent heart attacks and strokes for people with acute coronary syndrome, a common condition that occurs when a clot blocks blood supply to the heart and can trigger a heart attack. The drug should be approved at 2.5 milligram dose, the panel said today in a statement on its website.
The decision comes after the Food and Drug Administration refused to back Xarelto for acute coronary syndrome patients this month, raising questions about the drug’s usefulness in reducing risk. Acute coronary syndrome is one of many uses Bayer and J&J have pursued for Xarelto; the drug is also marketed to people with irregular heartbeats and to prevent blood clots after hip and knee surgeries, and Bayer says it will probably eventually bring in more than 2 billion euros ($2.59 billion) a year in sales.
The European agency’s backing is recognition that Xarelto “can help save lives” among heart-attack patients, Kemal Malik, head of global development for Leverkusen, Germany-based Bayer, said in a statement.
While rates of bleeding, a feared side effect of blood thinners, were higher in acute coronary syndrome patients who took Xarelto, there wasn’t an increase in deadly hemorrhages in the brain or elsewhere in the body, Bayer said.
Acute coronary syndrome results in hospitalization for about 1.2 million people in the U.S. each year. Existing treatments include AstraZeneca Plc’s Brilinta and Eli Lilly & Co.’s Effient.
J&J owns rights to Xarelto in the U.S., while Bayer sells the drug in Europe.