Bayer AG (BAYN) rose the most in 10 months in Frankfurt trading after its blood thinner Xarelto won an advisory panel’s support as a treatment to prevent stroke in patients with the most common abnormal heart rhythm.
The drug, known chemically as rivaroxaban, was recommended for atrial fibrillation patients in a 9-2 vote with one abstention by advisers to the Food and Drug Administration meeting yesterday in Adelphi, Maryland. The agency is scheduled to decide whether to approve Xarelto by Nov. 5 and isn’t required to follow the recommendation.
The FDA staff recommended Sept. 6 that the medicine not be cleared for the heart patients because study results didn’t show it would be effective or safe enough. Warfarin, the current standard of care, wasn’t adequately used in a Xarelto study, potentially giving the new treatment from Bayer and partner Johnson & Johnson (JNJ) an unfair advantage, the agency’s staff said in its report.
Xarelto is as effective as “warfarin for patients that really need it,” Philip Sager, an advisory panel member, said. “There are obviously a number of other things that will have to be discussed and worked out.”
Bayer rose 1.46 euros, or 3.7 percent, to 40.43 euros at 9:56 a.m. in Frankfurt. The stock gained as much as 5.5 percent, its biggest intraday increase since November. Bayer lost 7.5 percent on Sept. 6 after the FDA staff report was published.
Atrial fibrillation affects more than 2 million Americans, according to the American Heart Association. J&J, based in New Brunswick, New Jersey, markets Xarelto in the U.S. and pays royalties on sales to Bayer, based in Leverkusen, Germany. The German drugmaker sells Xarelto outside the U.S. The partners won U.S. approval July 1 to market the drug for prevention of blood clots after knee or hip replacement surgery.
Physicians for the past half-century have used warfarin, a drug that requires constant monitoring and dose adjustments, to prevent stroke in atrial fibrillation patients, according to the New England Journal of Medicine.
The FDA staff also said the Xarelto results showed excess strokes in patients using the blood thinner who then switched to warfarin. The report suggested the companies conduct a transition trial.
Robert Temple, director of the FDA’s office of drug evaluation, said the panel members differed on what patients would benefit most from the new blood thinner. Several advisers, including Sager, voiced concern that Xarelto should be approved only for patients who don’t respond to other treatments.
“The recommendation for approval is potentially a Pyrrhic victory,” Mark Purcell, a London-based analyst for Barclays Capital, wrote in a note to clients today. “The FDA may very well opt for a label that restricts Xarelto to a small part of the market.” Purcell rates Bayer’s shares “equal weight.”
Panel members didn’t support J&J’s claim that Xarelto should be labeled superior to warfarin. Martin Rose, a clinical reviewer with the FDA, said J&J indicated to him that it would no longer pursue a superiority claim as the company sought U.S. approval.
Peter DiBattiste, global therapeutic area head of cardiovascular and metabolism at J&J, disputed Rose’s claim.
“Our position has not changed,” DiBattiste said.
Warfarin’s dose must be maintained in a specific range to keep the blood from clotting and also from getting too thin and putting patients at risk of severe bleeding, particularly brain hemorrhage, Jack Scannell, an analyst with Sanford Bernstein Ltd. in London, said in a note Sept. 7.
Recommended Treatment Range
The comparison group of patients given warfarin during the Xarelto study was in the recommended treatment range just 55 percent of the time. In separate studies of Xarelto’s rivals, the comparison groups on warfarin did better.
Patients remained in the therapeutic window 64 percent of the time during a trial of Boehringer Ingelheim GmbH’s Pradaxa, approved by the FDA for the heart patients in October, and 62 percent of the time for Pfizer Inc. (PFE) and Bristol-Myers Squibb Co. (BMY)’s apixaban, known as Eliquis, now being tested in clinical trials.
The New England Journal of Medicine, which published the results, said Xarelto was tested on higher-risk patients.
The panel discussed the use of warfarin in the Xarelto study at length.
“This can get us into some very dangerous territory,” said Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation. Nissen voted against Xarelto approval.
Even if the FDA agrees with the staff report and rejects Xarelto, Scannell said 30 percent of drugs that the agency originally turns away are approved.
A delay in approval may erase any advantage Xarelto might have had by beating Eliquis to the market. Eliquis presented “best-in-class” results Aug. 28 at the European Society of Cardiology’s conference in Paris. The pill had a 31 percent lower risk of major bleeding, a safety concern with blood thinners, compared with warfarin and an 11 percent reduced risk of dying, the first time a warfarin replacement has saved lives in a clinical trial.
About 300,000 patients have been prescribed Pradaxa, Glenn Silver, a spokesman for Boehringer, said in an e-mail.
Bayer said sales of the blood thinner Xarelto will reach at least 2 billion euros ($2.8 billion) a year outside the U.S., leaving its peak sales estimate unchanged even if the drug doesn’t get FDA regulatory approval in atrial fibrillation patients.
The drugmaker is “confident” it will reach the sales target in markets outside the U.S., including Europe and Japan, said Astrid Kranz, a spokeswoman for the company.