Investing.com – filed a lawsuit Monday in New York federal court accusing of making false and misleading claims in advertisements for its prostate cancer drug Erleada, alleging the campaign hurts sales prospects for Bayer’s competing drug Nubeqa.
The lawsuit challenges J&J’s February 2026 advertising campaign claiming Erleada showed a 51% reduction in risk of death compared to Nubeqa based on what J&J called a “real world head-to-head analysis.” Bayer asked a judge to order J&J to correct its claims. The two drugs are androgen receptor inhibitors used in combination with androgen deprivation therapy to treat metastatic castration-sensitive prostate cancer, a disease that kills over 35,000 men annually in the U.S.
Bayer’s Nubeqa (NYSE:BAY) received FDA approval for doublet therapy with ADT in June 2025, while J&J’s Erleada (NYSE:JNJ) obtained approval for the same treatment in September 2019. Nubeqa sales totaled €1.63 billion globally in the first nine months of 2025, approximately $1.81 billion using a September 30, 2025 conversion rate.
The lawsuit argues J&J’s data analysis does not meet FDA standards for substantial evidence required to support a superior efficacy claim between prescription drugs. Bayer contends the analysis relied on a retrospective observational study using real-world data from electronic medical records and administrative claims, not a randomized controlled clinical trial. The complaint states that during 97% of the study period from August 5, 2022 to June 30, 2025, Nubeqa was prescribed off-label for doublet therapy before its June 2, 2025 FDA approval.
Bayer claims the study compared 1,460 patients taking Erleada with 287 patients taking Nubeqa, with the smaller Nubeqa group prescribed off-label for specific clinical reasons not captured in the data. The lawsuit alleges this created selection bias and fundamental non-comparability between the two patient groups, making J&J’s mortality comparison invalid.
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