A new type of blood thinner approved on Monday is the first shown in testing to prevent repeat strokes without significantly increasing a person’s bleeding risk.
Most patients who survive a clot-related stroke end up on a blood thinner, and many take more than one for a period of time. But combining blood thinners increases a person’s risk of dangerous internal bleeding. The new drug, Sunharbo from Bayer, promises to address the problem.
People who suffered a stroke due to
A new type of blood thinner approved on Monday is the first shown in testing to prevent repeat strokes without significantly increasing a person’s bleeding risk.
Most patients who survive a clot-related stroke end up on a blood thinner, and many take more than one for a period of time. But combining blood thinners increases a person’s risk of dangerous internal bleeding. The new drug, Sunharbo from Bayer, promises to address the problem.
People who suffered a stroke due to blood clots that don’t come from the heart had a 26% lower risk of a second stroke after taking Sunharbo on top of a blood thinner in a large, late-stage study.
“All the indirect evidence suggests that it’s safer than aspirin,” said Dr. Ashkan Shoamanesh, a stroke neurologist at McMaster University in Canada and one of the study’s lead investigators.
Wall Street expects the U.S. Food and Drug Administration approval will provide a much-needed boost for Bayer. It is facing generic competition for some of its biggest selling drugs, including a blood thinner it co-markets with Johnson & Johnson.
Analysts have forecast that Sunharbo could bring in up to $4.5 billion in yearly sales, though it may soon have a competitor if a rival product from Bristol Myers and J&J succeeds in studies.
Blood thinners have been blockbusters for drug companies. Bayer and J&J’s drug, Xarelto, sold nearly $7 billion a year before it started going generic. Another popular blood thinner, Eliquis, drives $14 billion in annual sales for its makers and is about to lose patent protection.
With some older and less expensive blood thinners available, Bayer will have to work that much harder to convince insurers that the added protection is worth paying for a costlier branded product.
Bayer’s new drug will have a list price of $748.50 for a 30-day supply.
There are some people already gearing up for Sunharbo. Earlier this year, doctors told Lindsay Johnson that the funny feeling in her left arm had been a stroke. She was shocked. At age 41, the otherwise healthy mother of an 11- and a 14-year-old, Johnson worried about having another stroke.
“A medication that can help prevent repeat stroke and can help with less bleeding risk is huge for somebody like me,” said Johnson, of Cleveland, whose doctor said she would be a good candidate for this new drug. “I’ll take all the help I can get.”
Second strokes are more likely to be disabling, said Johnson’s neurologist, Dr. Andrew Russman, the medical director of the Comprehensive Stroke Center at the Cleveland Clinic, who wants to put Johnson on the drug indefinitely. But questions remain as to whether insurers will cover it and how well it will work long term.
“There’s still a huge unmet need for better therapies to prevent stroke,” said Dr. Hooman Kamel, a neurologist at Weill Cornell Medicine and NewYork-Presbyterian. Kamel wasn’t involved with the Bayer study, but has consulted with the company and other drugmakers developing anticlotting drugs. “Despite all the progress we’ve made, it’s still the second leading cause of death worldwide.”
Drugs like aspirin work by preventing platelets in the blood from sticking together and forming clots. Sunharbo works differently, blocking a protein that drives clot formation called Factor XI, which is how it helps prevent strokes.
That protein plays only a minor role in stopping bleeding, which scientists think explains why the drug doesn’t increase a person’s bleeding risk. The approval is the first for this type of drug class.
“Recurrence rates in stroke have not changed for the past 20 years,” said Sebastian Guth, chief operating officer of Bayer’s worldwide pharmaceutical business. “This is really practice-changing.”Write to Alex Janin at alex.janin@wsj.com
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