FDA untitled letter skewers Esperion’s Nexlizet TV ad

The FDA is apparently not charmed by the mischievous “Lipid Lurkers” in an Esperion Therapeutics commercial for cholesterol-lowering drug Nexlizet. An untitled letter (PDF) from the agency, dated Dec. 19 and posted publicly this week, takes aim at multiple aspects of the TV ad, including its use of troublemaking animated yellow creatures to symbolize LDL or “bad” cholesterol. Imagery of the so-called Lipid Lurkers “entering and exiting the various scenes in an artery while swimming around and towards the viewer, diving, doing flips, collecting and sticking to arterial walls, and talking to one another in the ‘arterial environment’ where blood is constantly flowing” may distract viewers from and interfere with their comprehension of the ad’s major statement about the drug’s risks and side effects, according to the regulator. The FDA also criticized a claim in the ad’s voiceover and corresponding onscreen text that the bempedoic acid in Nexlizet is “the only nonstatin FDA approved to lower bad cholesterol and reduce the risk of heart attack in statin-intolerant patients.” That’s “misleading,” according to the letter, because other nonstatins—“certain PCSK9 inhibitors,” per the FDA—have been approved to reduce LDL-C and risk of cardiovascular events regardless of whether a patient is able to tolerate statins. Indeed, PCSK9 inhibitors approved for those purposes include Amgen’s Repatha and Regeneron and Sanofi’s Praluent, both of which have been proven effective in statin-intolerant patients. The agency gave Esperion 15 working days to respond to its concerns. The drugmaker didn’t immediately reply to a Fierce Pharma Marketing request for comment. The Lipid Lurkers made their debut in the spring of 2024 in a campaign covering both Nexlizet and its sibling drug Nexletol, arriving shortly after both earned FDA label expansions. The campaign started with a highly targeted digital-first approach to build traction and awareness before expanding to traditional outlets like TV, as Eric Warren, then Esperion’s chief commercial officer, explained in an interview with Fierce at the time. Warren also discussed the process of selecting from more than a dozen mascot concepts, with the Lipid Lurkers ultimately winning out thanks to the way they balance being both “menaces” and “cute little guys.” “I’ve seen other companies where it’s all shock and fear, as to the risk associated with elevated LDL-C—you know, ‘you could die.’ We wanted to make it a little bit lighter than that,” he said. “So, we got the patients’ attention, but we didn’t scare the heck out of them.”