The US FDA approved Bayer’s Sunharbo to prevent repeat strokes in patients. The drug treats those who had a stroke not caused by heart clots or a mini-stroke. Sebastian Guth said, "We believe that we're bringing a practice-changing innovation to the market." Bayer hopes this drug helps their future sales.
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Sunharbo is approved as a once-daily treatment to prevent another stroke in patients whose previous stroke was not caused by a clot from the heart. It is also approved for patients who have had a high-risk transient ischemic attack, often called a "mini-stroke."
Stroke is a leading cause of death in the United States, and Bayer estimates that each year approximately 795,000 people in the US are likely to experience a stroke.
Bayer is betting on the drug to help offset declining revenue from older blockbuster medicines, such as Xarelto, which has faced competition from cheaper generics after losing patent protection.
"We believe that we're bringing a practice-changing innovation to the market," Sebastian Guth, president of Bayer's US operations, said in an interview.
"There have not been any changes in the recurrence rates of stroke over the past 20 years, so there's a genuine and very significant excitement" for the drug, Guth said.
The company has previously described the drug as having blockbuster potential, which typically means at least $1 billion in annual sales. Guth said asundexian would be an important part of the company's future success.
The approval was based on data from a late-stage study that showed the drug reduced both the frequency and severity of recurrent ischemic strokes, which are caused by clogged arteries.
China's drug regulator approved Sunharbo late last month.
Reporting by Sneha S K in Bengaluru and Michael Erman in New York; Editing by Bill Berkrot