Bayer has filed a lawsuit against Johnson & Johnson and Janssen Biotech, alleging the companies made false and misleading claims about the efficacy of its prostate cancer drug Nubeqa compared to the latter’s Erleada.
The suit, filed in the U.S. District Court for the Southern District of New York, seeks injunctive relief and damages under the Lanham Act, according to a Feb. 23 news release. Bayer said J&J’s superiority claims are based on flawed retrospective real-world data rather than the head-to-head clinical trials required by the FDA to establish definitive efficacy.
Bayer cited multiple issues with the analysis, including a significant imbalance in patient cohort size — Erleada patients outnumbered Nubeqa patients five to one — and insufficient follow-up time. The company also said Nubeqa was not approved for monotherapy during 97% of the analysis period, rendering comparisons invalid.
In a statement to Becker’s, Johnson & Johnson defended the findings and methodology, saying the analysis showed a 51% reduction in risk of death with Erleada and was designed in line with regulatory standards for real-world evidence. The company said the lawsuit reflects “an obvious misunderstanding” of those frameworks.
Bayer said at least 60% of patients in both treatment groups started therapy after June 2023, making a full 24-month follow-up impossible before the analysis ended in June 2025.
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