U.S. judge rejects Bayer bid over J&J drug claims

Summary

A U.S. judge denied Bayer's bid to block Johnson & Johnson's advertising claims for prostate cancer drug Erleada.

Why this matters

The ruling affects how drugmakers can use real-world evidence in marketing disputes involving competing treatments. It also concerns claims tied to prostate cancer, a disease that affects hundreds of thousands of U.S. men each year.

A U.S. judge denied Bayer’s request for an injunction to block Johnson & Johnson from advertising that its prostate cancer drug Erleada cuts the risk of death by 51%.

In a decision issued Friday night, U.S. District Judge Dale Ho in Manhattan said Bayer had not shown it was likely to succeed on the merits of its false advertising claims or that it faced irreparable harm. Bayer had argued that Johnson & Johnson’s campaign threatened to erode trust in Bayer’s prostate cancer drug, Nubeqa.

Bayer sued Johnson & Johnson on Feb. 23, alleging the company falsely claimed patients had a “51% reduction in risk of death” if treated with Erleada instead of Nubeqa, based on testing that met “rigorous” U.S. Food and Drug Administration standards.

The German drugmaker said those claims were unreliable because most Nubeqa patients in the study received the drug off-label. Bayer also said the Food and Drug Administration did not review Johnson & Johnson’s retrospective, real-world analysis as a substitute for traditional clinical trials.

In his 41-page decision, Ho said Johnson & Johnson’s statements accurately reflected the study’s conclusions, and Bayer had not identified methodological errors “so substantial” that the claims were materially false or misleading.

“Based on the current record,” Ho wrote, “the methodological choices made by the authors of the study were not errant or out-of-step within the relevant scientific community.”

Bayer spokeswoman Sue Ann Pentecost said in a statement: “Bayer continues to believe the full body of evidence supports its false advertising claims and looks forward to the court’s determination on the merits of the case.”

Johnson & Johnson said the ruling was “a win for scientific exchange and a strong win for patients…. Real-world evidence helps clinicians make informed treatment decisions, especially when head-to-head clinical trials data are not available.”

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