A lengthy legal tussle is expected after Novo Nordisk launched a lawsuit against Eli Lilly last week, alleging that its advertising campaigns for its obesity and diabetes drugs are designed to deliberately mislead consumers, reports CNBC.
Novo is specifically taking issue with ads that cite what it called “outdated” clinical trials to compare the highest doses of Lilly’s medicines to lower doses of Novo’s drugs. For example, those campaigns don’t include new evidence about Novo’s recently approved high-dose version of its obesity injection, Wegovy, which entered the market in March and brings weight loss that’s more comparable to Lilly’s products.
“That leaves them with the inevitable conclusion that Lilly’s medicines are superior to Novo’s, and that’s not accurate,” protested John Kuckelman, Novo’s group general counsel.
The lawsuit comes after Lilly “refused to pull down or correct certain ads despite a formal cease-and-desist request in April”, he said.
In the case, filed in New Jersey, Novo asked the court to permanently stop Lilly from running the ads and to issue corrective advertising. Novo is also seeking financial damages, though it’s unclear how much.
The company said it has also warned Lilly that if the ads are not removed voluntarily, it plans to seek a preliminary injunction in the coming days to block them immediately while the case proceeds.
Lilly said it stands “firmly behind our advertising”. It added that the gold standard for comparing medicines is a “robustly designed, well-conducted head-to-head clinical trial”, like the one it uses in its ad campaigns to compare its obesity injection, Zepbound, to Wegovy.
That remains the only study that directly pits those drugs against each other.
“It is truthful, transparent, and grounded in the most direct scientific evidence available,” Lilly said. “We will continue to focus on the science and defend against this lawsuit vigorously.”
The suit comes as Novo wages an aggressive battle against Lilly to regain market share in the GLP-1 space, positioning its new obesity pill, strategic price cuts and the new high-dose Wegovy to compete with its rival’s top-selling obesity injection Zepbound and diabetes counterpart Mounjaro.
Issues with ‘outdated’ trials
Novo said it is specifically bringing federal and state unfair competition and false advertising claims, including under the Lanham Act, on which pharmaceutical companies have relied in the past to hold competitors accountable for deceptive advertising.
It alleges that Lilly’s campaigns across television and social media are harmful because consumers often rely on advertising to form their understanding of GLP-1s, unlike healthcare professionals, who have access to the full scientific evidence available.
The lawsuit cites a TV commercial presenting Zepbound and Wegovy in a direct side-by-side comparison, stating visually and verbally that patients on Lilly’s drug lose 22.6kg on average compared with around 15kg on the 2.4mg dose of Novo’s treatment. That’s based on a previous head-to-head clinical trial comparing the highest doses of Zepbound to the 1.7- and 2.4-mg doses of Wegovy.
But Novo said in the suit that a more recent study shows that the high-dose 7.2mg dose of Wegovy helped patients lose 21.3kg on average, which is “clinically consistent” with Zepbound’s weight loss in Lilly’s most recent rigorous trial on the drug.
Novo added that no head-to-head trials have compared the highest doses of Wegovy and Zepbound currently available on the market, so Lilly has “no basis to make these comparative claims” that its drugs are more effective.
“While it may have been accurate to say that before 7.2mg became available for Wegovy, it is no longer accurate to say that,” said Kuckelman.
“They have, we think, a legal obligation, but even more important, they have a responsibility to patients to share accurate information.”
The suit added that the Zepbound TV commercial has received more than 700m impressions since it began airing around the end of April, which demonstrates the scale of the competitive harm to Novo. It alleges that Lilly takes the same approach when comparing the efficacy of Mounjaro and Ozempic in its ads, withholding new data on a higher dose of Novo’s drug that was approved more than four years ago.
“We feel that we have a very strong case here where we can show that Lily has indeed misled consumers with the advertising,” Kuckelman said.
CNBC article – Novo Nordisk sues Eli Lilly, alleging misleading GLP-1 advertising (Open access)
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