Bayer AG and Johnson & Johnson failed to win the backing of a U.S. advisory panel to expand the use of their blood-thinner Xarelto, raising another challenge in the companies’ repeated effort to sell the drug to a bigger group of heart patients.
Xarelto shouldn’t be approved to help prevent heart attacks and strokes 90 days after patients experience serious chest pain or cardiac illness, a condition known as acute coronary syndrome, advisers to the Food and Drug Administration voted 10-0 with one abstention. It’s the companies’ third attempt to gain FDA clearance for such patients.
J&J, which owns U.S. rights to Xarelto, is seeking to limit the amount of time people would take the medicine in a compromise with FDA reviewers. The agency said the data on the effectiveness of the drug wasn’t strong enough to make up for a risk of bleeding that increases the longer patients take the medicine. Panelist Sanjay Kaul urged the FDA not to set a precedent that allows drugmakers to cherry-pick treatment times.
“It sends the wrong message,” Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles, said during yesterday’s meeting in Silver Spring, Maryland.
During the first review of Xarelto for acute coronary syndrome, agency advisers questioned whether follow up on 1,300 patients whose information was missing would change the outcome of data showing the benefit of the drug. J&J found 900 patients.
Missing data on 400 patients is still “intolerable,” Kaul said.
“It’s not just that the data are fragile, it’s that the therapy has both benefits and harms and in that context the quality of the data becomes increasingly important,” Steven Nissen, a panelist and chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation, said during the meeting.
J&J, the world’s largest seller of health-care products, plans to work with the FDA to solve the issues raised with Xarelto, known chemically as rivaroxaban.
“We appreciate the thoroughness of the committee’s review and continue to believe rivaroxaban, in addition to the current standard of care, may help provide patients with ACS additional protection against life-threatening cardiovascular events such as death, heart attack and stroke,” Paul Burton, vice president of clinical development for J&J’s Janssen Research & Development, said in a statement.
Leverkusen, Germany-based Bayer, which sells the drug in Europe, also will work with J&J to help the FDA complete its review, Kemal Malik, a member of the Bayer HealthCare Executive Committee and head of global development, said in a statement.
Acute coronary syndrome is an umbrella term for situations when the blood supplied to the heart is blocked. Xarelto and its competitors are trying to replace the 50-year-old blood-thinner warfarin, which is commonly used against the condition.
Bristol-Myers Squibb Co. and Pfizer Inc.’s Eliquis and Boehringer Ingelheim GmbH’s Pradaxa aren’t approved for use against acute coronary syndrome. AstraZeneca Plc’s Brilinta and Eli Lilly & Co.’s Effient are on the market as treatments for acute coronary syndrome. Those drugs work by preventing platelets in patients’ blood from sticking together and forming a clot.
The FDA in 2012 and last March rejected Xarelto as a treatment to prevent heart attack and stroke in patients with acute coronary syndrome. J&J disputed the FDA’s decision after the latest rebuff and while the agency denied the appeal, the FDA offered a path forward that included limiting how long patients use the drug.
The FDA initially approved Xarelto in July 2011 to prevent blood clots in patients undergoing knee and hip surgeries. The drug’s use has since been extended to patients with irregular heartbeats and deadly leg and lung blood clots.
Xarelto generated $847 million in estimated sales for New Brunswick, New Jersey-based J&J in 2013, and 841.9 million euros ($1.15 billion) for Bayer, according to data compiled by Bloomberg.
Acute coronary syndrome leads to 1.2 million hospitalizations each year. Xarelto was approved in Europe in May to prevent heart attacks and strokes in acute coronary syndrome patients.