Bloomberg the Company & Products

Bloomberg Anywhere Login

Bloomberg

Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.

Company

Financial Products

Enterprise Products

Media

Customer Support

  • Americas

    +1 212 318 2000

  • Europe, Middle East, & Africa

    +44 20 7330 7500

  • Asia Pacific

    +65 6212 1000

Communications

Industry Products

Media Services

Follow Us

Bayer, J&J’s Xarelto Wins EU Backing for Expanded Use

Don't Miss Out —
Follow us on:

March 22 (Bloomberg) -- 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.

To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

Please upgrade your Browser

Your browser is out-of-date. Please download one of these excellent browsers:

Chrome, Firefox, Safari, Opera or Internet Explorer.