Johnson & Johnson and Bayer’s legacy blood thinner Xarelto has
had a tough year with competitors picking up steam and prescriptions
leveling off. But in a hard-to-treat artery disease, the drug just
posted a new trial in recent post-surgery patients.
A combination of Xarelto and aspirin reduced the risk of major limb
and cardiovascular events by 15% over aspirin alone in symptomatic
peripheral artery disease (PAD) patients who had recently undergone
surgery to unblock arteries in their legs, according to data presented
Saturday at the American College of Cardiology scientific sessions.
At 28 weeks of treatment, 17.3% of patients treated with a
Xarelto-aspirin combo suffered acute limb ischemia, major amputation for
vascular cause, heart attack, ischemic stroke or cardiovascular death
compared with 19.9% in the solo aspirin arm.
The study also showed that while patients treated with Xarelto showed
higher rates of bleeding, there wasn’t a higher rate of severe bleeding
events in the Xarelto arm, including intracranial or fatal bleeds.
Around 10 million U.S. adults and 200 million patients worldwide suffer from PAD each year, according to a release.
Xarelto, which received a FDA nod in October 2018 to reduce the risk
of cardiovascular events in PAD patients, has faced an uphill climb
against high-performing blood thinners like Pfizer and Bristol Myers
Squibb’s Eliquis, which has taken the market by storm in recent years
after a slow initial launch.
In October, Xarelto scored an FDA nod––its eighth––to help prevent
blood clots for acutely ill patients without a high risk of bleeding
during and after hospitalization. The approval allowed patients who
start the drug in the hospital to follow up at home for a recommended
duration of 31 to 39 days, J&J said.
Of those eight approved indications, six specifically target blood
clots, giving the partners hope that a broad range of eligible patients
can help swing declining sales back around.
In 2019, Xarelto generated $2.3 billion in U.S. sales––a 6.6%
decrease from the year before. In April, J&J attributed the drug’s
ongoing decline to stagnating prescription figures stateside, growing
competition and the Medicare Part D “donut hole” provision.
Meanwhile, Eliquis has romped to the lead in the blood thinner
market, topping the U.S. warfarin alternative field in terms of market
share and then eventually overtaking warfarin itself. The partnered drug
hit $6.2 billion in worldwide sales last year.
https://www.fiercepharma.com/pharma/acc-j-j-bayer-s-blood-thinner-xarelto-scores-trial-win-artery-disease-after-surgery
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