J&J, Bayer fail to win U.S. OK for expanded Xarelto use

June 22, 2012

Johnson & Johnson and Bayer AG failed to gain U.S. approval to expand the use of their blood thinner Xarelto to prevent heart attacks and strokes in patients with serious chest pain or a previous heart attack.

The Food and Drug Administration declined to clear the treatment for acute coronary syndrome in a complete response letter, New Brunswick, N.J.-based J&J said Thursday in a statement. FDA advisers voted to recommend against approval May 23 because of missing data from 1,000 patients who withdrew from a late-stage trial of the drug.

The FDA decision may benefit New York-based Pfizer Inc. and Bristol-Myers Squibb Co., who expect approval June 28 for their rival drug Eliquis for a common heart arrhythmia known as atrial fibrillation, said Seamus Fernandez, an analyst at Leerink Swann & Co. in Boston. The availability of Eli Lilly and Co.’s Effient and AstraZeneca Plc’s Brilinta for acute coronary syndromes may delay further FDA action on Xarelto, he said.

“The FDA may not be motivated to urgently approve Xarelto for acute coronary syndrome without greater clarity,” he wrote in a note to clients today. “Commercially, we question whether the FDA’s recommended label for Xarelto in ACS would have any advantages over Effient or Brilinta. Given each drug’s slow launch, we question Xarelto’s commercial prospects as a third-to-market option.”

J&J is confident of the drug’s benefits for patients with acute coronary syndrome, Paul Burton, of the company’s Janssen Research & Development unit, said in the statement. “We will continue to work with the FDA to fully address their questions as quickly as possible,” he said.

Acute coronary syndrome causes 1.2 million hospitalizations a year. The market for drugs to treat the condition may total more than $1 billion, according to Fernandez, who said Xarelto may eventually win approval. The delay could be as long as a year, he said.

J&J owns U.S. rights to the medicine while Leverkusen, Germany-based Bayer sells the drug in Europe.

Xarelto has been on the U.S. market since July 2011 to prevent blood clots in patients undergoing knee and hip surgeries. In November, the FDA approved the medicine to prevent strokes in patients with atrial fibrillation. The missing information in the clinical trial made it hard to interpret the data for Xarelto’s use for the wider group of heart patients, panel members said.

Almost 1,300 patients dropped out early of a 15,526-subject, final-phase study and withdrew consent for access to their health information. Researchers were able to follow up with 177 patients, confirming they were alive.

Xarelto is one of the medicines attempting to replace warfarin, a more than 50-year-old drug that requires constant monitoring and dose adjustments to keep blood from getting too thin and putting patients at risk of severe bleeding. Boehringer Ingelheim GmbH, a closely held company based in Ingelheim, Germany, won U.S. approval in 2010 to sell Pradaxa, its blood thinner to replace warfarin, for those with irregular heartbeats.

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