FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Novartis Sues Janssen for Claiming Superiority of its Psoriasis Drug

March 11, 2019
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Novartis filed a lawsuit accusing Janssen of falsely claiming that its plaque psoriasis drug Tremfya (guselkumab) is superior to Novartis’ product, Cosentyx (secukinumab).

The complaint specifically alleges the Johnson & Johnson subsidiary misrepresented data from comparative trials. On Dec. 12, 2018, Janssen announced the results of its ECLIPSE study, which included safety data for the two drugs. When presenting the data, Janssen allegedly omitted the most serious adverse events associated with its product, including malignancies and major adverse cardiac events.

“This omission is especially egregious because these adverse events are not in the prescribing information for Tremfya. In other words, these adverse events would be new information to dermatologists,” the lawsuit states.

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