'Misleading' Heart Drug Ad; JenaValve Deal Thwarted; SGLT2 Inhibitor to Prevent HF

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Source: MedPage Today

Original: https://www.medpagetoday.com/cardiology/generalcardiology/119399...

Published: Tue, 13 Jan 2026 14:48:54 -0500

The FDA has called Esperion Therapeutics' television commercial for Nexlizet (bempedoic acid and ezetimibe) false or misleading.[1] The advertisement claimed that Nexlizet was the only FDA-approved non-statin to reduce bad cholesterol and heart attack risk.[1][4] According to the FDA, such a claim mislabels the drug and violates the Federal Food, Drug, and Cosmetic Act.[1] Visualizations in advertising, like cartoon "lipid characters" in an artery, hinder the understanding of the main statement.[1] The FDA is requesting immediate action from Esperion, including discontinuing the misleading advertisements, and a written response within 15 business days.[1] This letter is an untitled letter dated December 19, 2025.[1]