A U.S. federal judge has rejected Bayer's request to prohibit Johnson & Johnson from running advertisements that claim its multi-billion dollar drug can reduce the risk of death from prostate cancer by half.
In a ruling issued on Friday evening, U.S. District Judge Dale Ho in Manhattan stated that Bayer failed to demonstrate a likelihood of success on the merits. Bayer's lawsuit argued that Johnson & Johnson's promotional campaign for its drug Erleada was causing irreparable harm and could undermine confidence in Bayer's own drug, Nubeqa.
Neither Bayer nor Johnson & Johnson immediately responded to requests for comment after hours.
Bayer sued Johnson & Johnson on February 23, accusing it of falsely claiming that, based on tests meeting "rigorous" U.S. Food and Drug Administration standards, patients using Erleada instead of Nubeqa experienced a "51% reduction in risk of death."
The German pharmaceutical company argued that the claim of Erleada's superior efficacy is unreliable because most Nubeqa patients were treated off-label. It also stated that the FDA did not review Johnson & Johnson's retrospective real-world analysis, which was used in place of traditional clinical trials.
In a 41-page decision, Judge Ho stated that Johnson & Johnson's advertising accurately reflected the conclusions of its study. He noted that Bayer did not identify "significant" methodological errors that would render the New Brunswick, New Jersey-based company's statements substantially false or misleading.
"The methodological choices made by the authors of this study were not erroneous or out of step within the relevant scientific community based on the current record," the judge wrote.
According to data from the National Cancer Institute, approximately 313,780 new cases of prostate cancer will be diagnosed in the United States in 2025, and about 35,770 men will die from the disease.
In 2025, global sales of Nubeqa totaled 2.39 billion euros ($2.81 billion), while sales of Erleada reached $3.57 billion.
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