J&J Ads Contain Misleading Safety Stats On Tremfya, Novartis Lawsuit Claims

Novartis has filed a lawsuit against Johnson & Johnson and its Janssen subsidiary, alleging that misleading safety information has been provided about the psoriasis drug Tremfya.

The complaint (PDF) was filed last week in the U.S. District Court for the District of Columbia, seeking an injunction to prevent Janssen from providing what Novartis says is false advertising. The lawsuit claims that the misleading safety data gives Tremfya an unfair advantage against the Novartis psoriasis drug, Cosentyx.

Tremfya marketing materials cherry-pick data from a recent study, according to the lawsuit. Known as the “ECLIPSE” study, the findings were published in December, and indicate that 84.5% of Tremfya patients achieved a score of 90 or higher on the Psoriasis Area Severity Index; compared to only 70% of Cosentyx patients. However, Novartis claims those materials do not contain key information from that study, which would paint a much different safety profile.

“Janssen presented data from the ECLIPSE study in a false and misleading manner in at least two presentations at conferences within the past two months and is continuing to do so right now,” the complaint states. “In these presentations, Janssen made claims that its Tremfya product was both superior and noninferior to Novartis’s Cosentyx product, but did not present key safety information. Rather, it chose to cherry-pick among the adverse events that were recorded in the study.”

Novartis claims that slides presented at the conferences left out several adverse events linked to Tremfya, including heart problems and cancer risks. However, there is a slide that notes, in small print, that the information is not included.

The misrepresentation makes Novartis’s Cosentyx look less safe than Tremfya by comparison, the lawsuit notes.

The complaint calls for a temporary restraining order against Johnson & Johnson and Janssen, seeking to prevent them from publishing new marketing material that uses data from ECLIPSE to compare Tremfya and Cosentyx. It also calls for the companies to pull all of its currently misleading marketing materials comparing the two using data from the study from circulation.

In 2017, Tremfya sales were only $63 million. In 2018, they increased to $544 million in sales worldwide.